Cleared Traditional

K915831 - THERMAL PROBE COVER

K915831 is an FDA 510(k) clearance for THERMAL PROBE COVER, manufactured by Vermont Medical, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K915831 · Vermont Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
161d
Days
Class 2
Risk

K915831 is an FDA 510(k) clearance for the THERMAL PROBE COVER. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Vermont Medical, Inc. (Bellows Falls, US). The FDA issued a Cleared decision on June 8, 1992 after a review of 161 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 Vermont Medical, Inc. devices

FDA 510(k) Submission Details - K915831

510(k) Number K915831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1991
Decision Date June 08, 1992
Days to Decision 161 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 129d · This submission: 161d
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 K915831.
KLEAR-TEMP
K926030 · Cas Medical Systems, Inc. · Feb 1994
HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO
K925006 · Deroyal Industries, Inc. · Jan 1994
OHIO INFANT WARMER SYSTEM
K921766 · Ohmeda Medical · Apr 1993
STABILET INFANT RADIANT WARMER MODEL 2000C
K913945 · Hill-Rom, Inc. · Feb 1992
OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM
K884160 · Ohmeda Medical · Nov 1988
INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS
K875270 · Air-Shields, Inc. · Jan 1988