Cleared Traditional

K812037 - TEMPERATURE MONITOR 130/131/133

K812037 is an FDA 510(k) clearance for TEMPERATURE MONITOR 130/131/133, manufactured by Medix Medical Electronics (U.S.A.), Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K812037 · Medix Medical Electronics (U.S.A.), Inc. · General Hospital
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Jul 1981
Decision
7d
Days
Class 2
Risk

K812037 is an FDA 510(k) clearance for the TEMPERATURE MONITOR 130/131/133. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Medix Medical Electronics (U.S.A.), Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1981 after a review of 7 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medix Medical Electronics (U.S.A.), Inc. devices

FDA 510(k) Submission Details - K812037

510(k) Number K812037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1981
Decision Date July 28, 1981
Days to Decision 7 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
122d faster than avg
Panel avg: 129d · This submission: 7d
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 610
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K812037.
SERIES 400 DISPOSABLE TEMPERATURE PROBE
K813639 · Yellow Springs Instrument Co., Inc. · Jan 1982
WA-2000 TEMPERATURE INDICATOR
K813402 · Wallach Surgical Devices, Inc. · Jan 1982
MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER
K813409 · Yellow Springs Instrument Co., Inc. · Dec 1981
PROBE COVER
K810474 · Narco Air-Shields · Mar 1981
TEMPERATURE FUNCTION BLOCK
K810173 · Honeywell, Inc. · Feb 1981
SHILEY TEMPERATURE MONITOR
K802147 · Shiley, Inc. · Sep 1980