Cleared Traditional

K801550 - 3M GERMICIDAL SURGICAL INCISE DRAPE

K801550 is the FDA 510(k) clearance for 3M GERMICIDAL SURGICAL INCISE DRAPE by 3M Company. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 441-day FDA review.

K801550 · 3M Company · General Hospital
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Sep 1981
Decision
441d
Days
Class 2
Risk

K801550 is an FDA 510(k) clearance for the 3M GERMICIDAL SURGICAL INCISE DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on September 17, 1981 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

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Submission Details

510(k) Number K801550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1980
Decision Date September 17, 1981
Days to Decision 441 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
312d slower than avg
Panel avg: 129d · This submission: 441d
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 145
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K801550.
CURITY PREMIUM CYSTOSCOPY TRAY
K820850 · The Kendal Co. · May 1982
ANAGO STERILE PRODUCTS
K813097 · Anago, Inc. · Mar 1982
STERILE ADHERENT DRAPES
K812809 · Abco Dealers, Inc. · Nov 1981
BACTERICIDAL INCISE DRAPE
K811871 · Surgikos, Inc. · Aug 1981
GATOR DRAPES
K811996 · The Anspach Effort, Inc. · Aug 1981
DISPOSABLE STERILE LAP SPONGE
K802980 · Anago, Inc. · Dec 1980