Cleared Traditional

INCU I (K102279) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102279 · Atom Medical Corporation · General Hospital
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Dec 2010
Decision
140d
Days
Class 2
Risk

K102279 is an FDA 510(k) clearance for the INCU I. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Atom Medical Corporation (Bunkyo-Ku, Tokyo, JP). The FDA issued a Cleared decision on December 29, 2010 after a review of 140 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Atom Medical Corporation devices

Submission Details

510(k) Number K102279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2010
Decision Date December 29, 2010
Days to Decision 140 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 129d · This submission: 140d
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 24
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K102279.
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GIRAFFE INCUBATOR
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GIRAFFE OMNIBED
K101788 · Ohmeda Medical · Jul 2010
OHMEDA MEDICAL GIRAFFE OMNIBED
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