Cleared Traditional

K820542 - SURGIKOS INCISE DRAPE

K820542 is an FDA 510(k) clearance for SURGIKOS INCISE DRAPE, manufactured by Surgikos, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K820542

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
Combination Product No
PCCP Authorized No
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.

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 228
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K820542.
ISOVIS WOUND PROTECTOR
K830270 · Ritmed, Inc. · Jun 1983
GORE-TEX BARRIER SURG. DRAPES & GOWNS
K822641 · W.L. Gore & Associates, Inc. · Jan 1983
BARRIER ANTIMICROBIAL INCISE DRAPE
K820543 · Surgikos, Inc. · Jul 1982
CURITY PREMIUM CYSTOSCOPY TRAY
K820850 · The Kendal Co. · May 1982
BOUNDARY SINGLE-USE CRANIOTOMY SHEET
K820758 · The Buckeye Cellulose Corp. · Apr 1982
DERMAFILE (CAT. # 38
K813360 · Exco, Inc. · Mar 1982