Cleared Traditional

K950422 - FIRST TOUCH DISPOSABLES TEMPERATURE PROBES

K950422 is an FDA 510(k) clearance for FIRST TOUCH DISPOSABLES TEMPERATURE PROBES, manufactured by First Touch Disposables, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 721-day FDA review.

K950422 · First Touch Disposables, Inc. · General Hospital
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Jan 1997
Decision
721d
Days
Class 2
Risk

K950422 is an FDA 510(k) clearance for the FIRST TOUCH DISPOSABLES TEMPERATURE PROBES. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by First Touch Disposables, Inc. (Wilmington, US). The FDA issued a Cleared decision on January 23, 1997 after a review of 721 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all First Touch Disposables, Inc. devices

FDA 510(k) Submission Details - K950422

510(k) Number K950422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1995
Decision Date January 23, 1997
Days to Decision 721 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
592d slower than avg
Panel avg: 129d · This submission: 721d
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 59
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K950422.
INFANT RADIANT WARMER - MODELS IW910 AND IW920
K970432 · Fisher & Paykel Electronics , Ltd. · May 1997
STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)
K970074 · Hill-Rom, Inc. · Apr 1997
KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
K964401 · Ludlow Technical Products · Feb 1997
INFANT WARMER SYSTEM
K963058 · Ohmeda Medical · Oct 1996
ACCUTEMP PROBE
K960080 · Kentec Medical, Inc. · May 1996
TEMPERATURE PROBE-TP150
K952800 · Contour Medical Technology, Inc. · Apr 1996