Cleared Traditional

K851379 - HEALTHCHECK DIGITAL THERMOMETER MODEL 1...

K851379 is the FDA 510(k) clearance for HEALTHCHECK DIGITAL THERMOMETER MODEL 1... by Healthcheck Corp.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K851379 · Healthcheck Corp. · General Hospital
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Apr 1985
Decision
4d
Days
Class 2
Risk

K851379 is an FDA 510(k) clearance for the HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Healthcheck Corp. (Cheshire, US). The FDA issued a Cleared decision on April 12, 1985 after a review of 4 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 Healthcheck Corp. devices

Submission Details

510(k) Number K851379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1985
Decision Date April 12, 1985
Days to Decision 4 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
125d faster than avg
Panel avg: 129d · This submission: 4d
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 319
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K851379.
TOSHIBA DIGITAL CLINICAL THERMOMTER
K852903 · Toshiba Medical Systems · Jul 1985
CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS
K852087 · Terumo Medical Corp. · Jun 1985
THERMOMED
K851704 · Draeger Medical, Inc. · May 1985
CLINICAL ELECTRONIC THERMOMETERS
K850244 · Sheridan Catheter Corp. · Apr 1985
HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR
K844201 · Mallinckrodt Critical Care · Mar 1985
TOSHIBA DIGITAL CLINICAL THERMOMETER
K844124 · Toshiba Medical Systems · Dec 1984