Cleared Traditional

K822423 - BABY TEMP PACIFIER

K822423 is an FDA 510(k) clearance for BABY TEMP PACIFIER, manufactured by Trp Energy Sensors, Inc.. The device is a Class 1 General Hospital device with product code FQZ cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K822423 · Trp Energy Sensors, Inc. · General Hospital
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Oct 1982
Decision
62d
Days
Class 1
Risk

K822423 is an FDA 510(k) clearance for the BABY TEMP PACIFIER. Classified as Thermometer, Clinical Color Change (product code FQZ), Class I - General Controls.

Submitted by Trp Energy Sensors, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1982 after a review of 62 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2900 - 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 Trp Energy Sensors, Inc. devices

FDA 510(k) Submission Details - K822423

510(k) Number K822423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1982
Decision Date October 13, 1982
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

FQZ Device Classification - Class 1, General Controls

Product Code FQZ Thermometer, Clinical Color Change
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FQZ Thermometer, Clinical Color Change

Devices cleared under the same product code (FQZ) and FDA review panel - the closest regulatory comparables to K822423.
CRY-ACTRACKERCAM
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TEMPO2-I DISPOSABLE THERMOMETERS
K790890 · Airlife, Inc. · Jun 1979
THERMOMETER, SINGLE USE, STRIP, TEMPADOT
K771038 · Organon, Inc. · Jun 1977