Cleared Traditional

K913486 - QUALTEX SURGICAL DRAPE

K913486 is the FDA 510(k) clearance for QUALTEX SURGICAL DRAPE by Deroyal Industries, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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.

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 159
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K913486.
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
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