Cleared Traditional

KOZY COMFORT INFANT POSITIONER (K062143) - FDA 510(k) Clearance

Class I General Hospital device.

K062143 · Alfred E Mann Inst. For Biomedical Engineering · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
89d
Days
Class 1
Risk

K062143 is an FDA 510(k) clearance for the KOZY COMFORT INFANT POSITIONER. Classified as Holder, Infant Position (product code FRP), Class I - General Controls.

Submitted by Alfred E Mann Inst. For Biomedical Engineering (Los Angeles, US). The FDA issued a Cleared decision on October 24, 2006 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5680 - 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 Alfred E Mann Inst. For Biomedical Engineering devices

Submission Details

510(k) Number K062143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2006
Decision Date October 24, 2006
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRP Holder, Infant Position
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5680
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.