Cleared Traditional

K844056 - THERMOCOUPLE SENSORS

K844056 is the FDA 510(k) clearance for THERMOCOUPLE SENSORS by Sensortek, Inc.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K844056 · Sensortek, Inc. · General Hospital
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Jan 1985
Decision
83d
Days
Class 2
Risk

K844056 is an FDA 510(k) clearance for the THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Sensortek, Inc. (Clifton, US). The FDA issued a Cleared decision on January 9, 1985 after a review of 83 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 Sensortek, Inc. devices

Submission Details

510(k) Number K844056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1984
Decision Date January 09, 1985
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 246
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K844056.
CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS
K852087 · Terumo Medical Corp. · Jun 1985
THERMOMED
K851704 · Draeger Medical, Inc. · May 1985
HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR
K844201 · Mallinckrodt Critical Care · Mar 1985
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