Cleared Traditional

K880513 - DISP. NON-MAGNETIC SURGICAL INSTRU. DRAPE

K880513 is an FDA 510(k) clearance for DISP. NON-MAGNETIC SURGICAL INSTRU. DRAPE, manufactured by Taub Industries. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K880513 · Taub Industries · General Hospital
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Mar 1988
Decision
31d
Days
Class 2
Risk

K880513 is an FDA 510(k) clearance for the DISP. NON-MAGNETIC SURGICAL INSTRU. DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Taub Industries (New York, US). The FDA issued a Cleared decision on March 11, 1988 after a review of 31 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 Taub Industries devices

FDA 510(k) Submission Details - K880513

510(k) Number K880513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1988
Decision Date March 11, 1988
Days to Decision 31 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
98d faster than avg
Panel avg: 129d · This submission: 31d
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 292
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K880513.
O.R. TOWELS (STERILE)
K890709 · Cypress Medical Products, Ltd. · Mar 1989
AM TM SYRGICAL DRAPES
K882643 · Henley Intl. · Mar 1989
PMS ANGIO DRAPE
K890471 · Professional Medical Services · Feb 1989
3M BRAND LASER PROTECTION SURGICAL DRAPES, 88XX
K874086 · 3M Company · Dec 1987
LASER RESISTANT DRAPE
K873141 · Baxter Healthcare Corp · Oct 1987
OPSITE SPECIALITY DRAPES
K872757 · Smith & Nephew, Inc. · Jul 1987