Cleared Traditional

K802639 - OHIO IC INCUBATOR

K802639 is an FDA 510(k) clearance for OHIO IC INCUBATOR, manufactured by Ohio Medical Products. The device is a Class 2 General Hospital device with product code FMZ cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K802639 · Ohio Medical Products · General Hospital
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Nov 1980
Decision
20d
Days
Class 2
Risk

K802639 is an FDA 510(k) clearance for the OHIO IC INCUBATOR. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 20 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 Ohio Medical Products devices

FDA 510(k) Submission Details - K802639

510(k) Number K802639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1980
Decision Date November 12, 1980
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
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 47
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K802639.
NEOCARE BABY-CONTROLLED INCUBATOR
K813238 · Vickers America Medical Corp. · Jan 1982
NEOCARE TEMPERATURE MONITOR
K810792 · Vickers America Medical Corp. · Apr 1981
140 NEOCARE AIR CONTROLLED INCUBATOR
K810067 · Vickers America Medical Corp. · Mar 1981
OHIO GC INCUBATOR
K802640 · Ohio Medical Products · Nov 1980
ISOLETTE INCUBATOR C-100
K802126 · Narco Air-Shields · Sep 1980
THERMA-SHIELD
K801461 · Olympic Medical Corp. · Jul 1980