Cleared Traditional

K832418 - OHIO TEMPERATURE SIMULATOR

K832418 is an FDA 510(k) clearance for OHIO TEMPERATURE SIMULATOR, manufactured by Airco/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 52-day FDA review.

K832418 · Airco/Ohio Medical Products · General Hospital
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Sep 1983
Decision
52d
Days
Class 2
Risk

K832418 is an FDA 510(k) clearance for the OHIO TEMPERATURE SIMULATOR. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Airco/Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 52 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 Airco/Ohio Medical Products devices

FDA 510(k) Submission Details - K832418

510(k) Number K832418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1983
Decision Date September 12, 1983
Days to Decision 52 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 129d · This submission: 52d
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 48
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K832418.
AMEDA AMECARE(R) NEONATAL INCUBATOR
K870222 · Hollister, Inc. · Jun 1987
AMEDA AMELETTE(R) NEONATAL INCUBATOR
K870223 · Hollister, Inc. · Jun 1987
OHIO(R) CARE PLUS INCUBATOR
K871399 · Ohmeda Medical · Jun 1987
C-200 INFANT INCUBATOR
K822656 · Narco Scientific · Oct 1982
C-300 INFANT INCUBATOR
K821896 · Narco Scientific · Jul 1982
OXYGENAIRE NURING INCUBATOR
K813239 · Vickers America Medical Corp. · Jan 1982