Cleared Traditional

K960080 - ACCUTEMP PROBE

K960080 is an FDA 510(k) clearance for ACCUTEMP PROBE, manufactured by Kentec Medical, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K960080 · Kentec Medical, Inc. · General Hospital
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May 1996
Decision
111d
Days
Class 2
Risk

K960080 is an FDA 510(k) clearance for the ACCUTEMP PROBE. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Kentec Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on May 1, 1996 after a review of 111 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5130 - 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 Kentec Medical, Inc. devices

FDA 510(k) Submission Details - K960080

510(k) Number K960080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date May 01, 1996
Days to Decision 111 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 129d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMT Device Classification - Class 2, Special Controls

Product Code FMT Warmer, Infant Radiant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5130
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 - FMT Warmer, Infant Radiant

All 60
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K960080.
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