Cleared Traditional

K903378 - MODEL C286 ISOLETTE INFANT INCUBATOR

K903378 is the FDA 510(k) clearance for MODEL C286 ISOLETTE INFANT INCUBATOR by Air-Shields Vickers, Inc.. It is a Class 2 General Hospital device (product code FMZ) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K903378 · Air-Shields Vickers, Inc. · General Hospital
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Oct 1990
Decision
77d
Days
Class 2
Risk

K903378 is an FDA 510(k) clearance for the MODEL C286 ISOLETTE INFANT INCUBATOR. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Air-Shields Vickers, Inc. (Hatboro, US). The FDA issued a Cleared decision on October 15, 1990 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5400 - 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 Vickers, Inc. devices

Submission Details

510(k) Number K903378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1990
Decision Date October 15, 1990
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMZ Incubator, Neonatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5400
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 - FMZ Incubator, Neonatal

All 27
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K903378.
OHIO CARE PLUS INCUBATOR
K943360 · Ohmeda Medical · Sep 1994
OHIO CARE PLUS INCUBATOR
K914487 · Ohmeda Medical · Dec 1991
OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION
K913154 · Ohmeda Medical · Sep 1991
OHMEDA - OHIO(R) CARE PLUS INCUBATOR
K901585 · Ohmeda Medical · Jun 1990
AMEDA AMECARE(R) NEONATAL INCUBATOR
K870222 · Hollister, Inc. · Jun 1987
AMEDA AMELETTE(R) NEONATAL INCUBATOR
K870223 · Hollister, Inc. · Jun 1987