Cleared Traditional

K970074 - STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)

K970074 is an FDA 510(k) clearance for STANILET FREESTANDING/CC INFANT/2000C I..., manufactured by Hill-Rom, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K970074 · Hill-Rom, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
85d
Days
Class 2
Risk

K970074 is an FDA 510(k) clearance for the STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D). Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on April 3, 1997 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hill-Rom, Inc. devices

FDA 510(k) Submission Details - K970074

510(k) Number K970074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1997
Decision Date April 03, 1997
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
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 K970074.
SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER
K971695 · Fisher & Paykel Electronics , Ltd. · Jul 1997
SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)
K971461 · Fisher & Paykel Electronics , Ltd. · Jul 1997
INFANT RADIANT WARMER - MODELS IW910 AND IW920
K970432 · Fisher & Paykel Electronics , Ltd. · May 1997
KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
K964401 · Ludlow Technical Products · Feb 1997
FIRST TOUCH DISPOSABLES TEMPERATURE PROBES
K950422 · First Touch Disposables, Inc. · Jan 1997
INFANT WARMER SYSTEM
K963058 · Ohmeda Medical · Oct 1996