Cleared Traditional

K102279 - INCU I

K102279 is an FDA 510(k) clearance for INCU I, manufactured by Atom Medical Corporation. The device is a Class 2 General Hospital device with product code FMZ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

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

FDA 510(k) Submission Details - K102279

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.

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 K102279.
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GIRAFFE INCUBATOR
K101778 · Ohmeda Medical · Jul 2010
GIRAFFE OMNIBED
K101788 · Ohmeda Medical · Jul 2010
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
K072512 · Datex-Ohmeda, Inc. · Oct 2007