Cleared Traditional

K874521 - MODIFIED THERMAL WELL TEMPERATURE SENSOR

K874521 is an FDA 510(k) clearance for MODIFIED THERMAL WELL TEMPERATURE SENSOR, manufactured by Mon-A-Therm, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K874521 · Mon-A-Therm, Inc. · General Hospital
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Jan 1988
Decision
65d
Days
Class 2
Risk

K874521 is an FDA 510(k) clearance for the MODIFIED THERMAL WELL TEMPERATURE SENSOR. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Mon-A-Therm, Inc. (St. Louis, US). The FDA issued a Cleared decision on January 6, 1988 after a review of 65 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 Mon-A-Therm, Inc. devices

FDA 510(k) Submission Details - K874521

510(k) Number K874521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1987
Decision Date January 06, 1988
Days to Decision 65 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 129d · This submission: 65d
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 404
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K874521.
MON-A-THERM'S SKIN TEMPERATURE SENSOR
K875234 · Mon-A-Therm, Inc. · Jan 1988
TYMPANIC TEMPERATURE SENSOR
K873205 · Respiratory Support Products, Inc. · Jan 1988
MODIFIED AIRWAY TEMPERATURE SENSOR
K874520 · Mon-A-Therm, Inc. · Jan 1988
MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR
K874523 · Mon-A-Therm, Inc. · Jan 1988
MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR
K874524 · Mon-A-Therm, Inc. · Jan 1988
HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR
K874568 · Mallinckrodt Critical Care · Jan 1988