Cleared Traditional

K954824 - PROTECTOR RETRACTOR & PROTECTOR RETRACT...

K954824 is an FDA 510(k) clearance for PROTECTOR RETRACTOR & PROTECTOR RETRACT..., manufactured by Medical Creative Technologies, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K954824 · Medical Creative Technologies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
186d
Days
Class 2
Risk

K954824 is an FDA 510(k) clearance for the PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Medical Creative Technologies, Inc. (Colmar, US). The FDA issued a Cleared decision on April 23, 1996 after a review of 186 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 Medical Creative Technologies, Inc. devices

FDA 510(k) Submission Details - K954824

510(k) Number K954824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1995
Decision Date April 23, 1996
Days to Decision 186 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 129d · This submission: 186d
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 K954824.
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
K964142 · Medline Industries, Inc. · Feb 1997
CONVERTORS DRAPE MATERIAL
K964125 · Allegiance Healthcare Corp. · Dec 1996
STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE
K962205 · Medline Industries, Inc. · Nov 1996
DEROYAL SURGICAL INSTRUMENT DRAPE
K950565 · Deroyal Industries, Inc. · Dec 1995
SURGICAL DRAPE KIT
K933148 · Nobelpharma USA, Inc. · Jun 1995
CIVCO PROBE BOOT/CORD COVER
K943393 · CIVCO Medical Instruments Co., Inc. · Feb 1995