Cleared Traditional

K880639 - ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE

K880639 is an FDA 510(k) clearance for ACCUTEMP(TM) TEMP. MONITIORING SYSTEM S..., manufactured by Human Technologies, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K880639 · Human Technologies, Inc. · General Hospital
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Nov 1988
Decision
260d
Days
Class 2
Risk

K880639 is an FDA 510(k) clearance for the ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Human Technologies, Inc. (St Petersburg, US). The FDA issued a Cleared decision on November 2, 1988 after a review of 260 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Human Technologies, Inc. devices

FDA 510(k) Submission Details - K880639

510(k) Number K880639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1988
Decision Date November 02, 1988
Days to Decision 260 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
131d slower than avg
Panel avg: 129d · This submission: 260d
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 564
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K880639.
MODEL 1000 ELECTRONIC CLINICAL THERMOMETER
K885187 · Mon-A-Therm, Inc. · Mar 1989
CLINICAL ELECTRONIC THERMOMETERS
K884765 · Sheridan Catheter Corp. · Feb 1989
DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS)
K883793 · Yellow Springs Instrument Co., Inc. · Nov 1988
TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA
K884119 · S & W Medico Teknik · Nov 1988
CLINICAL ELECTRONIC THERMOMETERS
K882127 · Sheridan Catheter Corp. · Aug 1988
CLINICAL ELECTONIC THERMOMETERS
K881368 · Sheridan Catheter Corp. · Jul 1988