Cleared Traditional

K871594 - BIRTHING ROOM WARMER

K871594 is an FDA 510(k) clearance for BIRTHING ROOM WARMER, 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 42-day FDA review.

K871594 · Air-Shields, Inc. · General Hospital
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Jun 1987
Decision
42d
Days
Class 2
Risk

K871594 is an FDA 510(k) clearance for the BIRTHING ROOM WARMER. 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 June 5, 1987 after a review of 42 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 - K871594

510(k) Number K871594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1987
Decision Date June 05, 1987
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 K871594.
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
WARM WEIGH MODELS I-20/W-30 INFANT SCALE
K872742 · Air-Shields, Inc. · Oct 1987
OHMEDA AUXILIARY POWER SYSTEM
K863208 · Ohmeda Medical · Oct 1986
DELIVERY ROOM WARMER
K861781 · Air-Shields, Inc. · Jul 1986
NEOCARE MODEL 800 INFANT RADIANT WARMER
K853926 · Draeger Medical, Inc. · Feb 1986