Cleared Traditional

K061280 - V-2200 INFANT INCUBATOR (FDA 510(k) Clearance)

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

K061280 · Neoforce Group, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jun 2006
Decision
50d
Days
Class 2
Risk

K061280 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 Neoforce Group, Inc. (Doylestown, US). The FDA issued a Cleared decision on June 27, 2006 after a review of 50 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 Neoforce Group, Inc. devices

Submission Details

510(k) Number K061280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2006
Decision Date June 27, 2006
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 128d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.