Cleared Traditional

K960080 - ACCUTEMP PROBE

K960080 is the FDA 510(k) clearance for ACCUTEMP PROBE by Kentec Medical, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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
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.

Device Classification

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 36
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K960080.
INCUWARMER
K971366 · Hill-Rom, Inc. · Jan 1998
STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)
K970074 · Hill-Rom, Inc. · Apr 1997
INFANT WARMER SYSTEM
K963058 · Ohmeda Medical · Oct 1996
RW RESUCITAIRE INFANT RADIANT WARMER
K940951 · Air-Shields, Inc. · May 1995
STABILET
K942904 · Hill-Rom, Inc. · Sep 1994
KLEAR-TEMP
K926030 · Cas Medical Systems, Inc. · Feb 1994