Cleared Traditional

STAT TEMP MODEL 4800 (K800396) - FDA 510(k) Clearance

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

K800396 · Baessler Medical Electronics,Inc. · General Hospital
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Mar 1980
Decision
28d
Days
Class 2
Risk

K800396 is an FDA 510(k) clearance for the STAT TEMP MODEL 4800. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Baessler Medical Electronics,Inc. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1980 after a review of 28 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 Baessler Medical Electronics,Inc. devices

Submission Details

510(k) Number K800396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1980
Decision Date March 25, 1980
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
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 216
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K800396.
DISPOSABLE TEMPERATURE PROBE
K821244 · Shiley, Inc. · May 1982
CONPHAR DIGITAL THERMOMETER
K813306 · Conphar, Inc. · Jan 1982
SHILEY TEMPERATURE MONITOR
K802147 · Shiley, Inc. · Sep 1980
PROBE COVER
K780593 · Abco Dealers, Inc. · Jun 1978
THERMOMETER, DIGITAL FEVER (MEDITEMP)
K760118 · Johnson & Johnson Professionals, Inc. · Jul 1976