Cleared Traditional

K875270 - INFANT INTENSIVE CARE SYSTEM VERTICAL H...

K875270 is an FDA 510(k) clearance for INFANT INTENSIVE CARE SYSTEM VERTICAL H..., manufactured by Air-Shields, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K875270 · Air-Shields, Inc. · General Hospital
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Jan 1988
Decision
28d
Days
Class 2
Risk

K875270 is an FDA 510(k) clearance for the INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Air-Shields, Inc. (Hatboro, US). The FDA issued a Cleared decision on January 19, 1988 after a review of 28 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 Air-Shields, Inc. devices

FDA 510(k) Submission Details - K875270

510(k) Number K875270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date January 19, 1988
Days to Decision 28 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
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 35
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K875270.
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
WARM WEIGH MODELS I-20/W-30 INFANT SCALE
K872742 · Air-Shields, Inc. · Oct 1987
BIRTHING ROOM WARMER
K871594 · Air-Shields, Inc. · Jun 1987
OHMEDA AUXILIARY POWER SYSTEM
K863208 · Ohmeda Medical · Oct 1986