Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard oscillometric blood pressure monitor and does not mention any AI or ML components or capabilities.

Therapeutic

No.
The device is used to measure blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.

Diagnostic

Yes.
The device is intended to measure systolic and diastolic blood pressure and pulse rate, which are indicators of a person's health status, aligning with the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions "main units" with "operating elements" and "inflatable cuff," indicating physical hardware components are integral to its function.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Function: The Automatic Digital Blood Pressure Monitor measures blood pressure and pulse rate by applying a cuff to the wrist or upper arm and using an oscillometric technique. This is a non-invasive measurement taken directly from the body.
Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens.

Therefore, since the device measures physiological parameters directly from the body without analyzing specimens in vitro, it falls outside the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Automatic Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist or the upper arm. It can be used at medical facilities or at home. The intended wrist circumference is 12.5~~20 cm and the intended arm circumference has several models: 23~~33 cm, 25~~35 cm, 22~~42 cm, 33~43 cm.

Product codes

DXN

Device Description

Automatic Digital Blood Pressure Monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual via non-invasive Oscillometric technique in which an inflatable cuff is wrapped around the wrist or the upper arm.It can be used at medical facilities or at home.

The Automatic Digital Blood Pressure Monitor main units have the operating elements of ON/OFF knob, SET key which can be user-friendly controlled.

Arm type Blood Pressure Monitor is equipped with inflatable cuff, while The wrist type Blood Pressure Monitor`s cuff is attached to the device body itself.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

wrist or the upper arm

Indicated Patient Age Range

adult person

Intended User / Care Setting

medical facilities or at home

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type;

In this clinical investigation, Arm sphygmomanometer had ninety patients (23-33cm: 49 males and 41 females, 25-35cm: 38 males and 52 females, 22-42cm: 48 males and 42 females, and 33-43cm: 38 males and 52 females) and Wrist sphygmomanometer also had ninety patients (43 males and 47 females) participated in the clinical study. Same simultaneous method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any adverse event or side-effect.

The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Pressure: ±3mmHg
Pulse: ±5%

Predicate Device(s)

K171833, K153552

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.

May 29, 2020

Xiamen Ants Bro Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, 510000 Cn

Re: K190982

Trade/Device Name: Automatic Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 1, 2019 Received: April 15, 2019

Dear Cassie Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K190982

Device Name Automatic Digital Blood Pressure Monitor

Indications for Use (Describe)

Automatic Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist or the upper arm. It can be used at medical facilities or at home. The intended wrist circumference is 12.5~~20 cm and the intended arm circumference has several models: 23~~33 cm, 25~~35 cm, 22~~42 cm, 33~43 cm .

Type of Use (Select one or both, as applicable)

Residential Use ( Per 31 CFR 801.4; Primary Residence )	One-Time Transaction ( 31 CFR 801.4; Subsequent Sale )
------------------------------------------------------------------------------	-----------------------------------------------------------------------------

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

AS-55G, AS-55A, AS-55M, AS-55F

510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

510(k) Owner's Name: Xiamen Ants Bro Technology Co., Ltd.

Establishment Registration Number: Applying

Address: 4th and 5th floor, No. 5 Building, Tech.&Innovation center, No. 289 Wengjiao Road, Haicang District, Xiamen China

Tel: +86-13459020349

Fax: +86-0592-6537633

Contact Person: Jane Xu (Manger)

Email: Sales1@asxd.com.cn

Application Correspondent:

Contact Person: Cassie Lee

Guangzhou GLOMED Biological Technology Co., Ltd.

Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China

Tel: +86 20 8266 2446

Email: regulatory@glomed-info.com

4

Sponsor: Xiamen Ants Bro Technology Co., Ltd. Subject Device: Automatic Digital Blood Pressure Monitor, Models: BA4110/AS-35A, BA6310/AS-35E, BA4900/AS-35W, AS-35K, AS-35I, AS-35H, AS-35X, AS-35J, AS-35L, AS-35F, AS-55G, AS-55A, AS-55M, AS-55F

2. Subject Device Information

Type of 510(k): Traditional

Common Name:Non-invasive blood pressure measurement systems

Classification Name: System, Measurement, Blood-Pressure, Non-Invasive

Trade Name:Automatic Digital Blood Pressure Monitor

Model Name: BA4110/AS-35A, BA6310/AS-35E, BA4900/AS-35W, AS-35K, AS-35I, AS-35H,

AS-35X, AS-35J, AS-35L, AS-35F, AS-55G, AS-55A, AS-55M, AS-55F

Review Panel: Cardiovascular

Product Code: DXN

Regulation Number: 870.1130

Regulatory Class: 2

3. Predicate Device Information

| Sponsor | Shenzhen Combei Technology
Co.,Ltd. | Dongguan Ageless Health Industrial
Co., Ltd. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Name
and Model | Digital Blood Pressure Monitor Wrist
Style
Models: BP800W, BP603W, BP880W,
BP885W, BPCB0A-2F, BP850W,
BP300W, BP810W, BP602W, BP608W,
BP606W, BP660W, BP830W, BP866W | AGE Automatic Upper Arm Blood
Pressure Monitor
Model: BA-801X, BA-802X, BA-803X,
BA-805X, BA-806X, BA-811X,
BA-812X, BA-813X, BA-821X,
BA-822X, BA-823X, BA-826X (X can be
A, B, C, D, E, F) |
| 510(k) Number | K171833 | K153552 |
| Product Code | DXN | DXN |
| Regulation | 870.1130 | 870.1130 |

5

Sponsor: Xiamen Ants Bro Technology Co., Ltd.

Subject Device:

Automatic Digital Blood Pressure Monitor, Models: BA4110/AS-35A, BA6310/AS-35E, BA4900/AS-35W, AS-35K, AS-351, AS-35H, AS-35X, AS-35J, AS-35L, AS-35F, AS-55G, AS-55A, AS-55M, AS-55F

Number
Regulation
Class	II	II

4. Device Description

Automatic Digital Blood Pressure Monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual via non-invasive Oscillometric technique in which an inflatable cuff is wrapped around the wrist or the upper arm.It can be used at medical facilities or at home.

The Automatic Digital Blood Pressure Monitor main units have the operating elements of ON/OFF knob, SET key which can be user-friendly controlled.

Arm type Blood Pressure Monitor is equipped with inflatable cuff, while The wrist type Blood Pressure Monitor`s cuff is attached to the device body itself.

5. Intended Use / Indications for Use

Automatic Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist or the upper arm.It can be used at medical facilities or at home. The intended wrist circumference is 12.5~~20 cm and the intended arm circumference has several models: 23~~33 cm, 25~~35 cm, 22~~42 cm, 33~43 cm.

6. Test Summary

Automatic Digital Blood Pressure Monitor has been evaluated the safety and performance by lab bench testing as following:

� Electrical safety test according to IEC 60601-1 and IEC 80601-2-30 standards
� Electromagnetic compatibility test according to IEC 60601-1-2 standard

6

Sponsor:	Xiamen Ants Bro Technology Co., Ltd.
Subject Device:	Automatic Digital Blood Pressure Monitor, Models: BA4110/AS-35A, BA6310/AS-35E, BA4900/AS-35W, AS-35K, AS-35I, AS-35H, AS-35X, AS-35J, AS-35L, AS-35F, AS-55G, AS-55A, AS-55M, AS-55F

� Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
� Usability test according to IEC62366 standard
� Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"

7. Summary of the clinical study

ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type;

In this clinical investigation, Arm sphygmomanometer had ninety patients (23-33cm: 49 males and 41 females, 25-35cm: 38 males and 52 females, 22-42cm: 48 males and 42 females, and 33-43cm: 38 males and 52 females) and Wrist sphygmomanometer also had ninety patients (43 males and 47 females) participated in the clinical study. Same simultaneous method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any adverse event or side-effect.

The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2.

8. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Automatic Digital Blood Pressure Monitor is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

| Elements of

Comparison	Subject Device	Predicate Device1	Predicate Device2	Verdict
				t
Elements of
Comparison	Subject Device	Predicate Device1	Predicate Device2	Verdict
Company	Xiamen Ants Bro
Technology Co., Ltd.	Shenzhen Combei
Technology
Co., Ltd.	Dongguan Ageless
Health Industrial
Co., Ltd.	--
Trade Name	Automatic Digital Blood
Pressure Monitor	Digital Blood
Pressure Monitor
Wrist Style	AGE Automatic
Upper Arm Blood
Pressure Monitor	--
Classification
Name	Non-invasive blood pressure
measurement system	Non-invasive blood
pressure
measurement
system	Non-invasive blood
pressure
measurement
system	SE
510(k)
Number	Applying	K171833	K153552	--
Product Code	DXN	DXN	DXN	SE
Intended Use /
Indications for
Use	Automatic Digital Blood
Pressure Monitor is intended
to measure the diastolic,
systolic blood pressures
and pulse rate of an adult
individual in hospitals,
hospital-type facilities and
home environments by using
a non-invasive oscillometric
technique in which an
inflatable cuff is wrapped
around the wrist or the upper
arm. The intended wrist
circumference is 12.5~20 cm
and the intended arm
circumference with four
sizes:
23~~33 cm, 25~~35 cm, 22~42
cm, 33~43 cm	The subject device
intended to
measure the
diastolic, systolic
blood pressures
and pulse rate of an
adult individual in
hospitals,
hospital-type
facilities and home
environments by
using a
non-invasive
oscillometric
technique in which
an
inflatable cuff (size:
12.5~~21.5cm(4.9~~8
.5in) is wrapped
around the single	AGE Automatic
Upper Arm Blood
Pressure Monitor is
for use by medical
professionals or at
home and is a
non-invasive blood
pressure
measurement
system intended to
measure the
diastolic and
systolic blood
pressures and
pulse rate of an
adult individual by
using a
non-invasive
technique in which
an inflatable cuff is	SE
Note 1
Elements of
Comparison	Subject Device	Predicate Device1	Predicate Device2	Verdict
		wrist.
The Subject device
is not intended to
be diagnostic
device.	wrapped around the
upper arm. The cuff
circumference is six
sizes.
Display	LCD Digital Display	LCD Digital Display	LCD Digital Display	SE
Measurement
Site	Wrist Upper Arm	Wrist	Upper Arm	SE
Cuff
Circumference	Wrist type:12.5~20 cm
Arm type:
23~~33 cm, 25~~35 cm, 22~~42 cm, 33~~43 cm	12.5~21.5cm	size A: 17cm--22cm
size B: 22cm--30cm
size C: 24cm--34cm
size D: 22cm--42cm
size E: 30cm--42cm
size F: 42cm--50cm	SE
Note 1
Inflation and
Deflation	Program-controlled and
automatic	Program-controlled
and automatic	Program-controlled
and automatic	SE
Measuring
Method	Non-invasive Oscillometric	Non-invasive
Oscillometric	Non-invasive
Oscillometric	SE
Measuring
scope	Pressure:
30mmHg~280 mmHg;
Pulse: 40 bpm~199 bpm	Pressure:
30mmHg~280
mmHg
Pulse: 40 bpm
~200 bpm	Pressure:
0mmHg~280
mmHg
Pulse: 40 bpm ~200
bpm	SE
Measuring
accuracy	Pressure: ±3mmHgPulse:
±5%	Pressure: ±
3mmHg
Pulse: ±5%	Pressure: ± 3mmHg
Pulse: ±5%	SE
Patient
Population	Adult	Adult	Adult	SE
Display	LCD Digital Display	LCD Digital Display	LCD Digital Display	SE
Power Supply	Wrist type:	2x 1.5V "AAA"	4x 1.5V "AA"	SE
Elements of
Comparison	Subject Device	Predicate Device1	Predicate Device2	Verdict
	2x 1.5V "AAA" batteries
Arm type:
4x 1.5V "AA" batteries/
4x 1.5V "AAA" batteries	batteries	batteries
Operation
condition	Temperature: +5 to +40 °C,
Humidity: 15 to 85%,
Pressure: 70.0k Pa - 106.0k
Pa	Temperature: +5 to
+40 °C,
Humidity: 15 to
85%,	Temperature: +5 to
+40 °C,
Humidity: 10 to
90%,
Pressure: 86.0k Pa

106.0k Pa | SE |
| Transport/stor
age
environment | Temperature:-25°C - +70°C,
Humidity:10%~95%,
Pressure: 70.0k Pa - 106.0k
Pa | Temperature:-10°C
+55°C,
Humidity:10%~
95%, | Temperature:-20°C
+65°C,
Humidity:10%~
95%,
Pressure: 86.0k Pa
106.0k Pa | SE |
| Safety | IEC 60601-1
IEC 60601-1-11
IEC 80601-2-30 | IEC 60601-1
IEC 60601-1-11
IEC 80601-2-30 | IEC 60601-1 | SE |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | SE |
| Dimensions
(L * D * H, unit:
mm) | BA4110 (AS-35A): 125 X
95 X 60
BA6310 (AS-35E):
140X105X65
A4900 (AS-35W):
133 X 75 X 33
AS-35H:
150 X 110 X 70
AS-351:
140 X 105 X 62
AS-35K: | -- | -- | SE
Note 2 |
| Elements of | Subject Device | Predicate Device1 | Predicate Device2 | Verdict |
| Comparison | | | | t |
| | AS-35X:
150 X 110 X 74 | | | |
| | AS-35J:
150X 110X 74 | | | |
| | AS-35L:
140 X 113 X 73 | | | |
| | AS-35F:
140X 10 X 63 | | | |
| | AS-55A:
78X 62 X 65 | | | |
| | AS-55G:
90 X 66 X26 | | | |
| | AS-55M:
89 X 66 X55 | | | |
| | AS-55F:
63 X 66 X69 | | | |
| Weight
(not include
battery) | BA4110 (AS-35A): about
300g | -- | -- | SE
Note 2 |
| | BA6310 (AS-35E): about
300g | | | |
| | A4900 (AS-35W): about
300g | | | |
| | AS-35H: about 300g AS-35I:
about 250g | | | |
| | AS-35K: about 250g | | | |
| | AS-35X: about 300g | | | |
| | AS-35J: about 328g | | | |
| | AS-35L: about 280g | | | |
| | AS-35F: about 281g | | | |
| | AS-55A: about 95g | | | |
| | AS-55G: about 95g | | | |
| | AS-55M: about 100g | | | |
| Elements of
Comparison | Subject Device | Predicate Device1 | Predicate Device2 | Verdict |
| | AS-55F: about 102g | | | |

7

Sponsor:

Xiamen Ants Bro Technology Co., Ltd.

Subject Device:

Automatic Digital Blood Pressure Monitor, Models: BA4110/AS-35A, BA6310/AS-35E, BA4900/AS-35W, AS-35K, AS-35I, AS-35H, AS-35X, AS-35J, AS-35L, AS-35F, AS-55G, AS-55A, AS-55M, AS-55F

8

Xiamen Ants Bro Technology Co., Ltd. Sponsor:

Subject Device:

Automatic Digital Blood Pressure Monitor, Models: BA4110/AS-35A, BA6310/AS-35E, BA4900/AS-35W, AS-35K, AS-35I, AS-35H, AS-35X, AS-35J, AS-35L, AS-35F, AS-55G, AS-55A, AS-55M, AS-55F

9

Xiamen Ants Bro Technology Co., Ltd. Sponsor:

Subject Device:

Automatic Digital Blood Pressure Monitor, Models: BA4110/AS-35A, BA6310/AS-35E, BA4900/AS-35W, AS-35K, AS-35I, AS-35H, AS-35X, AS-35J, AS-35L, AS-35F, AS-55G, AS-55A, AS-55M, AS-55F

10

Xiamen Ants Bro Technology Co., Ltd. Sponsor:

Automatic Digital Blood Pressure Monitor, Models: BA4110/AS-35A, BA6310/AS-35E, Subject Device: BA4900/AS-35W, AS-35K, AS-35I, AS-35H, AS-35X, AS-35J, AS-35L, AS-35F, AS-55G, AS-55A, AS-55M, AS-55F

11

Sponsor: Xiamen Ants Bro Technology Co., Ltd. Subject Device: Automatic Digital Blood Pressure Monitor, Models: BA4110/AS-35A, BA6310/AS-35E, BA4900/AS-35W, AS-35K, AS-351, AS-35H, AS-35X, AS-35J, AS-35L, AS-35F, AS-55G, AS-55A, AS-55M, AS-55F

Comparison in Detail(s):

Note 1:

Although "Intended Use / Indications for Use" and "Cuff Circumference" of the subject device are a little different from the predicate devices, but the different circumference range of subject device can be covered by the combination range of the predicate device K171833 and K153552, they are very similar. So these parameters' differences will not raise any safety or effectiveness issue.

Note 2:

Although the "Dimensions" and "Weight" of the subject device are a little different from the predicate devices, but all these factors are not the essential parameters of the device which will not affect the effectiveness, and all of them are complied with the safety standards IEC 60601-1. IEC 60601-1-11 and IEC 80601-2-30, which show the safety of subject device, so these parameters' differences will not raise any safety or effectiveness issue.

Final Conclusion:

The subject device Non-invasive Sphygmomanometer (Automatic Digital Blood Pressure Monitor) (Model: BA4110/AS-35A, BA6310/AS-35E, BA4900/AS-35W, AS-35K, AS-35I, AS-35H, AS-35X, AS-35J, AS-35L, AS-35F, AS-55G, AS-55M, AS-55M, AS-55F) has all features of the predicate device. Thus, the subject device is substantially equivalent to the predicate device.

Date of the summary prepared: May 27, 2020