Cleared Traditional

ELECTRONIC CLINICAL THERMOMETER TEMP PR (K820409) - FDA 510(k) Clearance

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

K820409 · Y · General Hospital
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Mar 1982
Decision
18d
Days
Class 2
Risk

K820409 is an FDA 510(k) clearance for the ELECTRONIC CLINICAL THERMOMETER TEMP PR. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Y (Mchenry, US). The FDA issued a Cleared decision on March 2, 1982 after a review of 18 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.

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Submission Details

510(k) Number K820409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1982
Decision Date March 02, 1982
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
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 194
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K820409.
B-D DIGITAL FEVER THERMOMETER
K852954 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985
SHILEY DISPOS. TEMP. PROBES
K833981 · Shiley, Inc. · Mar 1984
DISPOSABLE TEMPERATURE PROBE
K821244 · Shiley, Inc. · May 1982
SHILEY TEMPERATURE MONITOR
K802147 · Shiley, Inc. · Sep 1980
THERMOMETER, DIGITAL FEVER (MEDITEMP)
K760118 · Johnson & Johnson Professionals, Inc. · Jul 1976