Cleared Traditional

K082367 - INFANT SLEEP BEANIE

K082367 is an FDA 510(k) clearance for INFANT SLEEP BEANIE, manufactured by Life Innovations, LLC. The device is a Class 1 General Hospital device with product code FRP cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K082367 · Life Innovations, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
298d
Days
Class 1
Risk

K082367 is an FDA 510(k) clearance for the INFANT SLEEP BEANIE. Classified as Holder, Infant Position (product code FRP), Class I - General Controls.

Submitted by Life Innovations, LLC (Wellington, US). The FDA issued a Cleared decision on June 12, 2009 after a review of 298 days - an extended review 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: 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 Life Innovations, LLC devices

FDA 510(k) Submission Details - K082367

510(k) Number K082367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2008
Decision Date June 12, 2009
Days to Decision 298 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
169d slower than avg
Panel avg: 129d · This submission: 298d
Pathway characteristics
Predicate-based equivalence.

FRP Device Classification - Class 1, General Controls

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.