Cleared Traditional

K950565 - DEROYAL SURGICAL INSTRUMENT DRAPE

K950565 is an FDA 510(k) clearance for DEROYAL SURGICAL INSTRUMENT 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 308-day FDA review.

K950565 · Deroyal Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
308d
Days
Class 2
Risk

K950565 is an FDA 510(k) clearance for the DEROYAL SURGICAL INSTRUMENT DRAPE. 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 December 13, 1995 after a review of 308 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K950565

510(k) Number K950565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1995
Decision Date December 13, 1995
Days to Decision 308 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
179d slower than avg
Panel avg: 129d · This submission: 308d
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 K950565.
PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE
K954824 · Medical Creative Technologies, Inc. · Apr 1996
VOLMED OPERATION DRAPE
K955872 · Medal Intl. Sales Co., LLC · Mar 1996
CPR EYE TRAY
K960242 · Custom Pack Reliability · Mar 1996
SURGICAL DRAPE KIT
K933148 · Nobelpharma USA, Inc. · Jun 1995
OREX(R) O.R EQUIPMENT DRAPES
K945755 · Thantex Specialties, Inc. · May 1995
REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8
K946060 · Remington Medical, Inc. · Apr 1995