Cleared Traditional

K960241 - CPR GENERAL SURGERY TRAY

K960241 is the FDA 510(k) clearance for CPR GENERAL SURGERY TRAY by Custom Pack Reliability. It is a Class 2 General & Plastic Surgery device (product code LWI) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K960241 · Custom Pack Reliability · General & Plastic Surgery device
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Mar 1996
Decision
66d
Days
Class 2
Risk

K960241 is an FDA 510(k) clearance for the CPR GENERAL SURGERY TRAY. Classified as Ultrasound, Sinus (product code LWI), Class II - Special Controls.

Submitted by Custom Pack Reliability (Orlando, US). The FDA issued a Cleared decision on March 22, 1996 after a review of 66 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 892.1560 - the FDA general and plastic surgery 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.

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Submission Details

510(k) Number K960241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date March 22, 1996
Days to Decision 66 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 115d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LWI Ultrasound, Sinus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 & Plastic Surgery devices follow this clearance model.