Cleared Traditional

K901585 - OHMEDA - OHIO(R) CARE PLUS INCUBATOR

K901585 is an FDA 510(k) clearance for OHMEDA - OHIO CARE 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 79-day FDA review.

K901585 · Ohmeda Medical · General Hospital
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Jun 1990
Decision
79d
Days
Class 2
Risk

K901585 is an FDA 510(k) clearance for the OHMEDA - OHIO(R) CARE PLUS INCUBATOR. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Ohmeda Medical (Columbia, US). The FDA issued a Cleared decision on June 22, 1990 after a review of 79 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 - K901585

510(k) Number K901585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1990
Decision Date June 22, 1990
Days to Decision 79 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
50d faster than avg
Panel avg: 129d · This submission: 79d
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 K901585.
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
MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR
K900735 · Preemicare Corp. · May 1990
K-1 INFANT TRANSPORT SYSTEM
K895550 · K-1 Medical Products, Inc. · Dec 1989
NEONATAL INCUBATOR (ACCESSORY)
K895782 · Air-Shields Vickers, Inc. · Dec 1989
K901585 · OHMEDA - OHIO(R) CARE PLUS INCUBATOR
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