Cleared Traditional

K912910 - C100 INFANT INCUBATOR SHELF/MOUNT RAIL ...

K912910 is the FDA 510(k) clearance for C100 INFANT INCUBATOR SHELF/MOUNT RAIL ... 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 120-day FDA review.

K912910 · Air-Shields Vickers, Inc. · General Hospital
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Oct 1991
Decision
120d
Days
Class 2
Risk

K912910 is an FDA 510(k) clearance for the C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM. 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 30, 1991 after a review of 120 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Air-Shields Vickers, Inc. devices

Submission Details

510(k) Number K912910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1991
Decision Date October 30, 1991
Days to Decision 120 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 129d · This submission: 120d
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 K912910.
OHMEDA-OHIO CAE PLUS INCUBATOR
K962806 · Ohmeda Medical · Sep 1996
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