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510(k) Data Aggregation
K Number
K251694Device Name
safety lancet
Manufacturer
Tianjin Huahong Technology Co., Ltd.
Date Cleared
2025-06-26
(24 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Product Code :
FMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K244036Device Name
Heel Incision Safety Lancet (SteriHeel 2)
Manufacturer
SteriLance Medical (Suzhou) Inc.
Date Cleared
2025-02-26
(58 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Product Code :
FMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Heel Incision Safety Lancet is intended for capillary blood sampling from the heel of newborns, preemies and toddlers.
Device Description
Heel Incision Safety Lancet is comprised of Outer cover, Press carrier and Blade holder (include the blade). The press carrier provides an elastic force to puncture and ensure the blade can shrink back to the covers. The blade can be fired after press the press carrier. The blade holder is to protect the blade from triggering before use and form a sterile barrier to maintain the blade sterile. The device was sterilized by Radiation.
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K Number
K242680Device Name
LetsGetChecked Impress
Manufacturer
PrivaPath Diagnostics Ltd (dba LetsGetChecked)
Date Cleared
2025-01-13
(129 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Product Code :
FMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ImPress is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
Device Description
The LetsGetChecked ImPress is a single-use blood lancing tool equipped with an integral sharps injury prevention feature. It is intended for use by health care professionals in producing capillary whole blood samples from the upper arm. To use the device, the user first removes the device tabs to expose the two internally contained lancets. The plastic strip liner is then removed, exposing a layer of medical adhesive. The device is then placed on the upper arm. Activation occurs when the device is compressed against the arm, causing two contact-activated lancets to puncture the skin. The lancets automatically retract to a safe position, preventing sharps injury and re-activation. The device operates solely through mechanical means. During activation, the device generates a vacuum against the skin, which facilitates the emergence of microliter quantities of capillary blood from the puncture site.
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K Number
K243533Device Name
Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
Manufacturer
HLB Co., Ltd. Healthcare
Date Cleared
2025-01-13
(59 days)
Product Code
FMK, ORK
Regulation Number
878.4850Why did this record match?
Product Code :
FMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is intended for capillary blood sampling.
Device Description
The Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus are single-use, surgical steel devices housed in plastic, designed to puncture a fingertip for capillary blood sampling. They can be used anytime and anywhere to measure blood glucose levels in diabetic patients. The needle sleeve serves as a sterile barrier, sterilized to an SAL of 10-6 through irradiation. The product has a shelf life of 3 years.
The Sterilized Eol Auto Lancet includes a protective cap, handle, needle, button, lancing device, and two springs. To activate, simply remove the protective cap, place the button on the skin, and press the lancet. After use, the needle retracts into the device for safe handling.
The Sterilized Eol Lancet Plus includes a protective cap, handle, and needle. It can be used alone or with a lancing device that offers an adjustable tip and varying depth settings.
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K Number
K242664Device Name
gentleheel® Adult Incision Device
Manufacturer
GRI-Alleset, Inc.
Date Cleared
2024-11-05
(62 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Product Code :
FMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The gentleheel® Adult Incision Device is a single-use lancing device intended to obtain microliter capillary blood samples. The gentleheel® Adult Incision Device has a sharps prevention feature to protect the user from a needlestick injury.
Device Description
The gentleheel® Adult Incision Device is designed to be an easy to use, safe, one handed incision device for acquiring blood samples from the patient's finger to obtain sufficient blood volumes for capillary blood draws. The gentleheel Adult Incision Device utilizes a blade resulting in improved blood flow requirements. The welded plastic housing is designed to prevent accidental exposure to the blade, to be ergonomic for improved handling, and compatible with a human fingertip. The user is instructed to remove the trigger lock. When the gentleheel Adult Incision Device is placed against the patient's finger and the user presses the trigger mechanism it automatically makes the incision the blade in a continuous motion from inside the housing, into the fingertip, and then back within the housing. The trigger mechanism is no longer functional and the blade remains inside the housing through disposal. The entire device is discarded in a sharps container after use. The gentleheel Adult Incision Devices are provided sterile and are single patient use only. They are sterilized by Ethylene Oxide (EO) sterilization method.
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K Number
K242627Device Name
Safety Lancet
Manufacturer
Ningbo Medsun Medical Co., Ltd.
Date Cleared
2024-10-30
(57 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Product Code :
FMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.
Device Description
Safety Lancet could be divided into Model XA Pro and Model ZF.Each model has sharps protection features that it can reduce the occurrence of accidental needle sticks. The device is sterilized by Co-60 or e-beam gamma ray and for single use.The shelf life is 5 years. Model XA Pro has four versions according to the different three penetration depths, version XA1 Pro,version XA3 Pro,version XA5 Pro and version XA11 Pro. Model ZF also has four versions according to the different need type and material of slider, version ZF1,version ZF2,version ZF1 Blade and version ZF2 Blade.
Model XA Pro is composed of a protective cap, a knob (for depth settings), a front spring, housing, needle body with tri-bevel edge needle, a rear spring and a back cover (push button). The needle body with needle or blade is hidden inside the housing/protective cap. The device is colour coded for different versions.There is an integrated automatic inactivation system to prevent lancet reuse. When the back cover is pressed down, it drives the rear spring to compress downwards. The back cover support legs are flush with the inclined surface of the protruding line head of the housing. The needle is rotated and slided downwards under the force of the rear spring until it is disengaged from the inclined surface and fired forward for blood sampling, while compressing the front spring. The needle will be retracted automatically back into the housing after the puncture due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used.
Model ZF lancet is composed of spring, three-facet needle or blade, housing, and slider. The needle body with needle or blade is concealed within housing/slider. The lancets of different specifications are in different colors. There is an integrated automatic inactivation system to prevent lancet reuse. The spring is fixed at the bottom of the housing, and when the slider is pressed down, which drives the spring to compress downwards.The two locking points(blocked the needle) on the slider will be opened along the slope of the housing, the needle will be released to fire under the force of the spring for blood sampling. After the puncture is completed, the spring retracts to a relaxed state and synchronously pulls the needle body back into the housing. Therefore, the device cannot be re-used.
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K Number
K242316Device Name
Safety Lancet
Manufacturer
Ningbo Medsun Medical Co., Ltd.
Date Cleared
2024-08-28
(23 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Product Code :
FMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.
Device Description
Safety Lancet, could be divided into Model XY, Model XH and Model XA according to the design features and key functional elements.The device is sterilized by Gamma ray(Co-60 or e-beam) and for single use. The shelf life is 5 years. Product Structure of the Safety Lancet are summarized in the table below: Model XY is composed of a protective cap, slider, front spring, housing, needle body with a tri-bevel edge needle or blade, a rear spring, and a back cover. The needle body is hidden inside the housing/slider, and the housing is color-coded for different versions. Model XH is composed of a protective cap, front spring, housing, needle body, rear spring, and back cover. Model XA is composed of a protective cap, a knob (for depth settings), a front spring, housing, needle body with tri-bevel edge needle, a rear spring and a back cover (push button). The needle body with needle or blade is hidden inside the housing/protective cap. The device is colour coded for different versions. There is an integrated automatic inactivation system to prevent lancet reuse. When the slider is pressed, the slider pushes the two bosses of the needle holder backwards. The bosses move backwards over the short rib on the inner side of the housing, and the rear spring is pressed and activated to launch the needle forwards for blood sampling. The needle retracts automatically back into the housing after the puncture, due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used.
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K Number
K241848Device Name
MedtFine Safety Lancet
Manufacturer
Ningbo Caremed Medical Products Co. Ltd.
Date Cleared
2024-08-20
(54 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Product Code :
FMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The safety lancet is intended for capillary blood sampling.
Device Description
Sterile safety lancet consists of outer shell, middle sleeve, needle holder, spring, upper shell, back cover, small cover, needle. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle holder and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use and single person use only. The shelf-life of the product is 5 years. The device is for medical professionals and lay person use as an OTC use.
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K Number
K241750Device Name
Medifun Safety Lancet ( MSL1 series)
Manufacturer
Medifun Corporation
Date Cleared
2024-08-15
(58 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Product Code :
FMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Safety lancet is intended for capillary blood sampling.
Device Description
The Medifun Safety Lancet (MSL1 series) is designed to obtain capillary blood samples from the fingertip. The intended users include healthcare personnel, patients, and lay persons. According to the needle and color differences, the safety lancets have 6 models : MSL1-30, MSL1-28, MSL1-26, MSL1-23, MSL1-21, and MSL1-18. The safety lancets consist of the needle seat, main body, release platform, spring, and protective cap. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years. The lancets contain a safety feature. After use, the puncture mechanism retracts, rendering it unusable for a second time.
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K Number
K241627Device Name
Safety Lancet (XXXV)
Manufacturer
Tianjin Huahong Technology Co., Ltd.
Date Cleared
2024-06-20
(14 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Product Code :
FMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The safety lancet is intended for capillary blood sampling.
Device Description
The safety lancet is single use medical device, which is designed to collect capillary blood sample. Model XXXV, the safety lancets consist of needle core, button, housing and spring. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.
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