Cleared Traditional

DISPOSABLE PHARMASEAL TEMPERATURE MONITORING PROBE (K864397) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K864397 · American Pharmaseal Div. Ahsc · General Hospital
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Dec 1986
Decision
25d
Days
Class 2
Risk

K864397 is an FDA 510(k) clearance for the DISPOSABLE PHARMASEAL TEMPERATURE MONITORING PROBE. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by American Pharmaseal Div. Ahsc (Valencia, US). The FDA issued a Cleared decision on December 1, 1986 after a review of 25 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 American Pharmaseal Div. Ahsc devices

Submission Details

510(k) Number K864397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1986
Decision Date December 01, 1986
Days to Decision 25 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
104d faster than avg
Panel avg: 129d · This submission: 25d
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 200
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K864397.
BD FLEXIBLE DIGITAL THERMOMETER
K902624 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)
K882304 · Abco Dealers, Inc. · Jul 1988
THERMOMETER SHEATHS
K871465 · Abco Dealers, Inc. · May 1987
B-D DIGITAL FEVER THERMOMETER
K852954 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985
CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS
K852087 · Terumo Medical Corp. · Jun 1985
TERUMO DIGITAL CLINICAL THERMOMETER
K841740 · Terumo Medical Corp. · Jul 1984