Cleared Traditional

K913486 - QUALTEX SURGICAL DRAPE, MODIFICATION

K913486 is an FDA 510(k) clearance for QUALTEX SURGICAL DRAPE, manufactured by Deroyal Industries, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K913486 · Deroyal Industries, Inc. · General Hospital
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Feb 1992
Decision
183d
Days
Class 2
Risk

K913486 is an FDA 510(k) clearance for the QUALTEX SURGICAL DRAPE, MODIFICATION. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on February 5, 1992 after a review of 183 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 Deroyal Industries, Inc. devices

FDA 510(k) Submission Details - K913486

510(k) Number K913486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1991
Decision Date February 05, 1992
Days to Decision 183 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 129d · This submission: 183d
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 268
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K913486.
DISPOSABLE O.R. TOWEL, STERILE
K915740 · American Threshold Industries, Inc. · Jun 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
ARTHROSCOPY CAMERA DRAPE
K915214 · O.R. Concepts, Inc. · Jan 1992
QUALTEX MAGNETIC INSTRUMENT DRAPE
K914369 · Deroyal Industries, Inc. · Dec 1991
CONVERTORS SAFECARE GOWN & DRAPE MATERIAL
K913506 · Baxter Healthcare Corp · Oct 1991