Cleared Traditional

K850395 - THE FEVER-THERM A THERM. MEASURING DEVICE

K850395 is an FDA 510(k) clearance for THE FEVER-THERM A THERM. MEASURING DEVICE, manufactured by Kma, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K850395 · Kma, Inc. · General Hospital
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Aug 1985
Decision
193d
Days
Class 2
Risk

K850395 is an FDA 510(k) clearance for the THE FEVER-THERM A THERM. MEASURING DEVICE. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Kma, Inc. (Bethesda, US). The FDA issued a Cleared decision on August 13, 1985 after a review of 193 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Kma, Inc. devices

FDA 510(k) Submission Details - K850395

510(k) Number K850395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1985
Decision Date August 13, 1985
Days to Decision 193 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 129d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 611
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K850395.
MON-A-THERM SUBCUTANEOUS TEMP. SENSOR
K853392 · Mon-A-Therm, Inc. · Nov 1985
YSI MODEL 790 TELE-THERMOMETER
K853551 · Yellow Springs Instrument Co., Inc. · Sep 1985
CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY SYSTEM
K852454 · Gambro, Inc. · Aug 1985
B-D DIGITAL FEVER THERMOMETER
K852954 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985
TOSHIBA DIGITAL CLINICAL THERMOMTER
K852903 · Toshiba Medical Systems · Jul 1985
CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS
K852087 · Terumo Medical Corp. · Jun 1985