Cleared Traditional

K993407 - OHMEDA MEDICAL OMNIBED

K993407 is an FDA 510(k) clearance for OHMEDA MEDICAL OMNIBED, 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 89-day FDA review.

K993407 · Ohmeda Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
89d
Days
Class 2
Risk

K993407 is an FDA 510(k) clearance for the OHMEDA MEDICAL OMNIBED. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Ohmeda Medical (Columbia, US). The FDA issued a Cleared decision on January 5, 2000 after a review of 89 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

FDA 510(k) Submission Details - K993407

510(k) Number K993407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1999
Decision Date January 05, 2000
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
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 52
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K993407.
OHMEDA MEDICAL GIRAFFE INCUBATOR
K020547 · Ohmeda Medical · May 2002
OHMEDA MEDICAL GIRAFFE INCUBATOR
K010222 · Ohmeda Medical · Mar 2001
VERSALET 7700 CARE CENTER, MODEL # 7700
K993051 · Hill-Rom Air-Shields · Feb 2000
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
K993712 · Ohmeda Medical · Nov 1999
BABYTHERM 8000 LDR
K980886 · Draeger Medical, Inc. · May 1998
OHMEDA-OHIO CARE PLUS INCUBATOR
K974349 · Ohmeda Medical · Feb 1998