Cleared Traditional

K942905 - DISPOSABLE TEMPERATURE PROBE COVER

K942905 is an FDA 510(k) clearance for DISPOSABLE TEMPERATURE PROBE COVER, manufactured by Arbo Medical, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K942905 · Arbo Medical, Inc. · General Hospital
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Feb 1995
Decision
251d
Days
Class 2
Risk

K942905 is an FDA 510(k) clearance for the DISPOSABLE TEMPERATURE PROBE COVER. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Arbo Medical, Inc. (Stratford, US). The FDA issued a Cleared decision on February 27, 1995 after a review of 251 days - an extended review cycle.

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 Arbo Medical, Inc. devices

FDA 510(k) Submission Details - K942905

510(k) Number K942905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1994
Decision Date February 27, 1995
Days to Decision 251 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
122d slower than avg
Panel avg: 129d · This submission: 251d
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 37
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K942905.
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
HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO
K925006 · Deroyal Industries, Inc. · Jan 1994