Cleared Traditional

K943360 - OHIO CARE PLUS INCUBATOR

K943360 is the FDA 510(k) clearance for OHIO CARE PLUS INCUBATOR by Ohmeda Medical. It is a Class 2 General Hospital device (product code FMZ) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K943360 · Ohmeda Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
79d
Days
Class 2
Risk

K943360 is an FDA 510(k) clearance for the OHIO 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 September 29, 1994 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.

View all Ohmeda Medical devices

Submission Details

510(k) Number K943360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1994
Decision Date September 29, 1994
Days to Decision 79 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
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.

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 32
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K943360.
BABYTHERM 8000 LDR
K980886 · Draeger Medical, Inc. · May 1998
OHMEDA-OHIO CARE PLUS INCUBATOR
K974349 · Ohmeda Medical · Feb 1998
OHMEDA-OHIO CAE PLUS INCUBATOR
K962806 · Ohmeda Medical · Sep 1996
TYPE INTERFACE 9271/1 INCUBATOR/WARMER
K912000 · S & W Medico Teknik · Sep 1992
OHIO CARE PLUS INCUBATOR
K914487 · Ohmeda Medical · Dec 1991
OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION
K913154 · Ohmeda Medical · Sep 1991