Cleared Traditional

K020435 - WOUND PROTECTOR/RETRACTOR

K020435 is an FDA 510(k) clearance for WOUND PROTECTOR/RETRACTOR, manufactured by Applied Medical Resources Corp.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K020435 · Applied Medical Resources Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
66d
Days
Class 2
Risk

K020435 is an FDA 510(k) clearance for the WOUND PROTECTOR/RETRACTOR. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on April 15, 2002 after a review of 66 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 Applied Medical Resources Corp. devices

FDA 510(k) Submission Details - K020435

510(k) Number K020435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2002
Decision Date April 15, 2002
Days to Decision 66 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 129d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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.

Regulatory Peers - KKX Drape, Surgical

All 178
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K020435.
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