Cleared Traditional

K820542 - SURGIKOS INCISE DRAPE

K820542 is the FDA 510(k) clearance for SURGIKOS INCISE DRAPE by Surgikos, Inc.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K820542 · Surgikos, Inc. · General Hospital
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Jun 1982
Decision
92d
Days
Class 2
Risk

K820542 is an FDA 510(k) clearance for the SURGIKOS INCISE DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Surgikos, Inc. (Walker, US). The FDA issued a Cleared decision on June 2, 1982 after a review of 92 days - within the typical 510(k) review window.

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: 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 Surgikos, Inc. devices

Submission Details

510(k) Number K820542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1982
Decision Date June 02, 1982
Days to Decision 92 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 129d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 76
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K820542.
SINGLE-USE SURGICAL DRAPES
K833877 · Procter & Gamble Mfg. Co. · Jan 1984
LIGHT HANDLE COVER
K832278 · Concept, Inc. · Sep 1983
GORE-TEX BARRIER SURG. DRAPES & GOWNS
K822641 · W.L. Gore & Associates, Inc. · Jan 1983
CURITY PREMIUM CYSTOSCOPY TRAY
K820850 · The Kendal Co. · May 1982
STERILE ADHERENT DRAPES
K812809 · Abco Dealers, Inc. · Nov 1981
3M GERMICIDAL SURGICAL INCISE DRAPE
K801550 · 3M Company · Sep 1981