Cleared Traditional

K913154 - OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION

K913154 is an FDA 510(k) clearance for OHMEDA - OHIO CAR PLUS INCUBATOR, manufactured by Ohmeda Medical. The device is a Class 2 General Hospital device with product code FMZ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K913154 · Ohmeda Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
63d
Days
Class 2
Risk

K913154 is an FDA 510(k) clearance for the OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Ohmeda Medical (Columbia, US). The FDA issued a Cleared decision on September 13, 1991 after a review of 63 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.

FDA 510(k) Submission Details - K913154

510(k) Number K913154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1991
Decision Date September 13, 1991
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMZ Device Classification - Class 2, Special Controls

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 85
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K913154.
MODEL C386 ISOLETTE(R) INFANT INCUBATOR
K913291 · Air-Shields, Inc. · Nov 1991
SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM
K912909 · Air-Shields Vickers, Inc. · Nov 1991
C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM
K912910 · Air-Shields Vickers, Inc. · Oct 1991
MP4, MP4SI, IT4 INCUBATORS
K901157 · Mediprema · Mar 1991
MODEL C286 ISOLETTE INFANT INCUBATOR
K903378 · Air-Shields Vickers, Inc. · Oct 1990
INCUBATOR 8000
K900752 · Dragerwerk AG · Aug 1990
K913154 · OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION
Download PDF Ohmeda Medical