Cleared Traditional

K823054 - DRAPE, SURGICAL ANGIOGRAPHY

K823054 is an FDA 510(k) clearance for DRAPE, manufactured by Triad Medical Division. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K823054 · Triad Medical Division · General Hospital
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Jan 1983
Decision
86d
Days
Class 2
Risk

K823054 is an FDA 510(k) clearance for the DRAPE, SURGICAL ANGIOGRAPHY. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Triad Medical Division (Mchenry, US). The FDA issued a Cleared decision on January 12, 1983 after a review of 86 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 Triad Medical Division devices

FDA 510(k) Submission Details - K823054

510(k) Number K823054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1982
Decision Date January 12, 1983
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
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 293
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K823054.
LIGHT HANDLE COVER
K832278 · Concept, Inc. · Sep 1983
ISOVIS WOUND PROTECTOR
K832874 · Ritmed, Inc. · Sep 1983
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
SURGIKOS INCISE DRAPE
K820542 · Surgikos, Inc. · Jun 1982