Cleared Traditional

STERILE PLASTIC DRAPE (K913408) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K913408 · Acacia Laboratories, Inc. · General Hospital
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Mar 1992
Decision
226d
Days
Class 2
Risk

K913408 is an FDA 510(k) clearance for the STERILE PLASTIC DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Acacia Laboratories, Inc. (Santa Ana, US). The FDA issued a Cleared decision on March 12, 1992 after a review of 226 days - an extended review 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: 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 Acacia Laboratories, Inc. devices

Submission Details

510(k) Number K913408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1991
Decision Date March 12, 1992
Days to Decision 226 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 129d · This submission: 226d
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 23
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K913408.
GLOBAL SHOULDER O.R. DRAPE PACK
K941233 · Depuy, Inc. · Jul 1994
CONVERTORS OPTI-SORB DRAPE MATERIAL
K940702 · Baxter Healthcare Corp · Apr 1994
STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE
K924101 · Baxter Healthcare Corp · Apr 1994
CONVERTORS SAFECARE GOWN & DRAPE MATERIAL
K913506 · Baxter Healthcare Corp · Oct 1991
3M BRAND LASER PROTECTION SURGICAL DRAPES, 88XX
K874086 · 3M Company · Dec 1987
LASER RESISTANT DRAPE
K873141 · Baxter Healthcare Corp · Oct 1987