Who is the manufacturer of LUMISCOPE MODEL 2018 THERMOMETER?

Lumiscope Co., Inc. filed the 510(k) submission for LUMISCOPE MODEL 2018 THERMOMETER (K954792).

What is the FDA product code for LUMISCOPE MODEL 2018 THERMOMETER?

FLL. It is classified under 21 CFR 880.2910 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for LUMISCOPE MODEL 2018 THERMOMETER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like LUMISCOPE MODEL 2018 THERMOMETER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LUMISCOPE MODEL 2018 THERMOMETER

K954792 · Lumiscope Co., Inc. · FLL · Jun 21, 1996 · General Hospital

Device Facts

Record ID	K954792
Device Name	LUMISCOPE MODEL 2018 THERMOMETER
Applicant	Lumiscope Co., Inc.
Product Code	FLL · General Hospital
Decision Date	Jun 21, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2910
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Lumiscope Model 2018 Thermometer has the same intended use as the predicate device. It is indicated for use in the measurement of oral and axillary temperature. It is not intended for rectal (rectum) temperature measurement. The device also provides a clock function when not in the temperature mode. The Lumiscope Model 2018 Thermometer is intended for use by adults and may be used by the infant or pediatric patient population for measurements of axillary body temperature or for measurements of oral body temperature if the child is able to hold the thermometer beneath the tongue while his mouth is closed.

Device Story

Digital electronic thermometer; consists of flexible probe, connecting cord, and display unit. Input: thermal signal via transducer. Operation: standard electrical transducer design; converts thermal input to digital temperature reading. Output: LCD temperature display and audible alert. Secondary function: quartz clock. Used in home or clinical settings; operated by adults or caregivers. Provides temperature data to assist in fever monitoring and clinical decision-making.

Clinical Evidence

Bench testing only. Device meets ASTM E 1112-86 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature. Accuracy, precision, and repeatability confirmed. Materials identical to those used in other legally marketed devices.

Technological Characteristics

Electrical transducer design; flexible probe; 1.5V DC button battery; LCD display; slide switches for mode selection; temperature alert beeper. Complies with ASTM E 1112-86. Materials identical to predicate.

Indications for Use

Indicated for oral and axillary temperature measurement in adults, infants, and pediatric patients. Contraindicated for rectal use. Pediatric oral use requires child's ability to hold thermometer under tongue with mouth closed.

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Predicate Devices

Hanson Scale Co Clinical Electronic Thermometer - Model 7616-10

Related Devices

K060173 — ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS · ACON Laboratories, Inc. · Mar 17, 2006
K982140 — CLINICAL ELECTRONIC THERMOMETER · Valeo Corp. · Dec 8, 1998
K072641 — DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4. · Famidoc Technology Co., Ltd. · Nov 1, 2007
K212257 — Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 · Alicn Medical Shenzhen, Inc. · May 4, 2022
K092447 — DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES · Hangzhou Hua'An Medical & Health Instruments Co., · Jan 7, 2010

Submission Summary (Full Text)

{0} LUMISCOPE JUN 21 1996 K954792 # 510(k) SUMMARY - Lumiscope Model 2018 Thermometer This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. **Proprietary Name:** Lumiscope Model 2018 Thermometer **Common/Usual Name:** Digital Fever Thermometer with Quartz Clock Oral and Axillary Thermometer **Classification Name:** Clinical Electronic Thermometer (per 21 CFR 880.2910) **Legally Marketed Device:** Hanson Scale Co Clinical Electronic Thermometer - Model 7616-10 **Device Description:** The Lumiscope Model 2018 Thermometer is a thermometer of standard electrical transducer design, consisting of a flexible probe, connecting cord and display unit. The probe consists of a transducer and supporting plastic tube which houses the connection between the tube and cord. The display unit houses a 1.5V DC button battery, Liquid Crystal Display (LCD), slide switches for controlling the thermometer/clock mode and °F/°C mode, hour and minute set buttons, and temperature alert beeper. **Intended Use:** The Lumiscope Model 2018 Thermometer has the same intended use as the predicate device. It is indicated for use in the measurement of oral and axillary temperature. It is not intended for rectal (rectum) temperature measurement. The device also provides a clock function when not in the temperature mode. The Lumiscope Model 2018 Thermometer is intended for use by adults and may be used by the infant or pediatric patient population for measurements of axillary body temperature or for measurements of oral body temperature if the child is able to hold the thermometer beneath the tongue while his mouth is closed. **Technological Characteristics:** The Lumiscope Model 2018 Thermometer has the same technological features as the predicate device: the mode of operation, physical specifications, operational, and biological specifications are identical. **Performance Data:** The Lumiscope Model 2018 Thermometer meets the ASTM Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature (ASTM E 1112-86). Bench testing confirmed accuracy, precision and repeatability measurements specified in the labeling. For all body or fluid contacting materials, certification is made that the identical materials have been used in other legally marketed devices under the same use conditions. **Substantial Equivalence:** The information provided demonstrates that the Lumiscope Model 2018 Thermometer is substantially equivalent to the predicate device since the devices have the same intended use, principles of operation, and technological characteristics. **Contact Person:** ![img-0.jpeg](img-0.jpeg) Thomas C. Parnell ![img-1.jpeg](img-1.jpeg) E-2a HOME OFFICE: THE LUMISCOPE COMPANY, INC., 400 RARITAN CENTER PARKWAY, EDISON, NJ 08837 PHONE 908/225-5533 FAX 908/225-7047