Cleared Traditional

K953465 - KENTEMP

K953465 is an FDA 510(k) clearance for KENTEMP, manufactured by Kentron Health Care, Inc.. The device is a Class 2 General Hospital device with product code FLK cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K953465 · Kentron Health Care, Inc. · General Hospital
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Dec 1995
Decision
144d
Days
Class 2
Risk

K953465 is an FDA 510(k) clearance for the KENTEMP. Classified as Thermometer, Clinical Mercury (product code FLK), Class II - Special Controls.

Submitted by Kentron Health Care, Inc. (Hollywood, US). The FDA issued a Cleared decision on December 15, 1995 after a review of 144 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2920 - 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 Kentron Health Care, Inc. devices

FDA 510(k) Submission Details - K953465

510(k) Number K953465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1995
Decision Date December 15, 1995
Days to Decision 144 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 129d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLK Device Classification - Class 2, Special Controls

Product Code FLK Thermometer, Clinical Mercury
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2920
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 - FLK Thermometer, Clinical Mercury

All 10
Devices cleared under the same product code (FLK) and FDA review panel - the closest regulatory comparables to K953465.
CLINICAL MERCURY THERMOMETER
K897054 · Cypress Medical Products, Ltd. · Mar 1990
GLASS MERCURY FILLED THERMOMETERS
K893602 · Smith & Nephew United, Inc. · Aug 1989
DISPOSABLE THERMOMETERS
K822502 · Hudson Oxygen Therapy Sales Co. · Sep 1982
THERMOMETER SHEATHS
K813423 · Abco Dealers, Inc. · Dec 1981
THERMOMETERS
K813424 · Abco Dealers, Inc. · Dec 1981
DISPOSABLE TEMPERATURE PROBE
K792426 · Hospitak, Inc. · Jan 1980