Cleared Traditional

K802050 - TACKMER INCISE DRAPE

K802050 is the FDA 510(k) clearance for TACKMER INCISE DRAPE by American Convertors Div., American Pharmaseal. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K802050 · American Convertors Div., American Pharmaseal · General Hospital
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Sep 1980
Decision
22d
Days
Class 2
Risk

K802050 is an FDA 510(k) clearance for the TACKMER INCISE DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by American Convertors Div., American Pharmaseal (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 22 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 American Convertors Div., American Pharmaseal devices

Submission Details

510(k) Number K802050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1980
Decision Date September 16, 1980
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
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 162
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K802050.
BOUNDARY SINGLE-USE DRAPES
K802192 · Procter & Gamble Mfg. Co. · Sep 1980
BOUNDARY SINGLE-USE DRAPES
K802247 · Procter & Gamble Mfg. Co. · Sep 1980
LAP SPONGES CAT.#801-850
K802001 · Pollak (Intl.), Ltd. · Sep 1980
BARRIER TOWEL DRAPE
K801863 · Surgikos, Inc. · Aug 1980
BARRIER APERTURED DRAPE
K801864 · Surgikos, Inc. · Aug 1980
WHITE KNIGHT SUPPLEMENTAL DRAPE
K800928 · G.D. Searle and Co. · May 1980