Cleared Traditional

K090284 - RES-Q INFANT WEDGE AND SLING

K090284 is an FDA 510(k) clearance for RES-Q INFANT WEDGE AND SLING, manufactured by Cr Enterprises, LLC. The device is a Class 1 General Hospital device with product code FRP cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K090284 · Cr Enterprises, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
120d
Days
Class 1
Risk

K090284 is an FDA 510(k) clearance for the RES-Q INFANT WEDGE AND SLING. Classified as Holder, Infant Position (product code FRP), Class I - General Controls.

Submitted by Cr Enterprises, LLC (Frisco, US). The FDA issued a Cleared decision on June 5, 2009 after a review of 120 days - within the typical 510(k) review window.

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 Cr Enterprises, LLC devices

FDA 510(k) Submission Details - K090284

510(k) Number K090284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2009
Decision Date June 05, 2009
Days to Decision 120 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
9d faster than avg
Panel avg: 129d · This submission: 120d
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.