Cleared Traditional

K842132 - TYCOS SELF-CHECK/DIGITAL FEVER THERMO

K842132 is the FDA 510(k) clearance for TYCOS SELF-CHECK/DIGITAL FEVER THERMO by Sybron Corp.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K842132 · Sybron Corp. · General Hospital
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Jul 1984
Decision
49d
Days
Class 2
Risk

K842132 is an FDA 510(k) clearance for the TYCOS SELF-CHECK/DIGITAL FEVER THERMO. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Sybron Corp. (Walker, US). The FDA issued a Cleared decision on July 18, 1984 after a review of 49 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 Sybron Corp. devices

Submission Details

510(k) Number K842132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1984
Decision Date July 18, 1984
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 332
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K842132.
HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR
K844201 · Mallinckrodt Critical Care · Mar 1985
TOSHIBA DIGITAL CLINICAL THERMOMETER
K844124 · Toshiba Medical Systems · Dec 1984
TERUMO DIGITAL CLINICAL THERMOMETER
K841740 · Terumo Medical Corp. · Jul 1984
TEMPROBE MONITOR
K840648 · Vital Signs, Inc. · Jun 1984
SHILEY DISPOS. TEMP. PROBES
K833981 · Shiley, Inc. · Mar 1984
HI-LO TEMP TYMPANIC TEMP. SENSOR
K832635 · Mallinckrodt Critical Care · Oct 1983