Cleared Traditional

K913408 - STERILE PLASTIC DRAPE

K913408 is an FDA 510(k) clearance for STERILE PLASTIC DRAPE, manufactured by Acacia Laboratories, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 226-day FDA review.

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

FDA 510(k) Submission Details - K913408

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.

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 166
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K913408.
QUALTEX TUBE/CORD ORGANIZER
K921350 · Deroyal Industries, Inc. · Aug 1992
BARRIER DRAPE SHEET WITH SYMETRY FABRIC
K920995 · Johnson & Johnson Medical, Inc. · May 1992
MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP
K920517 · Trinity Laboratories, Inc. · May 1992
QUALTEX SURGICAL DRAPE, MODIFICATION
K913486 · Deroyal Industries, Inc. · Feb 1992
ARTHROSCOPY CAMERA DRAPE
K915214 · O.R. Concepts, Inc. · Jan 1992
QUALTEX MAGNETIC INSTRUMENT DRAPE
K914369 · Deroyal Industries, Inc. · Dec 1991