Cleared Traditional

K061856 - V-2200 INFANT INCUBATOR

K061856 is an FDA 510(k) clearance for V-2200 INFANT INCUBATOR, manufactured by Atom Medical, Inc.. The device is a Class 2 General Hospital device with product code FMZ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K061856 · Atom Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
90d
Days
Class 2
Risk

K061856 is an FDA 510(k) clearance for the V-2200 INFANT INCUBATOR. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Atom Medical, Inc. (Ivyland, US). The FDA issued a Cleared decision on September 28, 2006 after a review of 90 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 - K061856

510(k) Number K061856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2006
Decision Date September 28, 2006
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 83
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K061856.
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
K072512 · Datex-Ohmeda, Inc. · Oct 2007
MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX
K070291 · Medix I.C.S.A. · Sep 2007
OHMEDA MEDICAL GIRAFFE OMNIBED
K071175 · Ge Healthcare · Jul 2007
VERSALET 7700 CARE CENTER
K053399 · Draeger Medical Infant Care, Inc. · Aug 2006
V-2200 INFANT INCUBATOR
K061280 · Neoforce Group, Inc. · Jun 2006
INFANT INCUBATOR, MODEL CHS-I1000
K040910 · Choong Wae Medical Corp. · Apr 2004
K061856 · V-2200 INFANT INCUBATOR
Download PDF FDA Summary Atom Medical, Inc.