Cleared Traditional

K102226 - DUAL INCU I

K102226 is an FDA 510(k) clearance for DUAL 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 148-day FDA review.

K102226 · Atom Medical Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
148d
Days
Class 2
Risk

K102226 is an FDA 510(k) clearance for the DUAL 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 January 4, 2011 after a review of 148 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.

FDA 510(k) Submission Details - K102226

510(k) Number K102226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2010
Decision Date January 04, 2011
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
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 68
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K102226.
Giraffe OmniBed Carestation CS1
K152814 · Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · Mar 2016
Giraffe Incubator Carestation CS1
K152809 · Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · Dec 2015
INFANT INCUBATOR
K132543 · Bistos Co., Ltd. · Jul 2014
INCU I
K102279 · Atom Medical Corporation · Dec 2010
NEO-SERVO I
K102710 · Atom Medical Corporation · Dec 2010
GIRAFFE INCUBATOR
K101778 · Ohmeda Medical · Jul 2010