Cleared Traditional

K970554 - CONVERTORS SMS DRAPES

K970554 is an FDA 510(k) clearance for CONVERTORS SMS DRAPES, manufactured by Allegiance Healthcare Corp.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K970554 · Allegiance Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
103d
Days
Class 2
Risk

K970554 is an FDA 510(k) clearance for the CONVERTORS SMS DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on May 27, 1997 after a review of 103 days - within the typical 510(k) review window.

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 Allegiance Healthcare Corp. devices

FDA 510(k) Submission Details - K970554

510(k) Number K970554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1997
Decision Date May 27, 1997
Days to Decision 103 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 129d · This submission: 103d
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 296
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K970554.
BOUFFANT CAP
K972187 · American Seal Co. · Sep 1997
DRAPE, SURGICAL-LATEX
K970891 · Protek Medical Products, Inc. · Aug 1997
SURGICAL DRAPES
K971159 · International Medsurg Connection · Jun 1997
STERILE DISPOSABLE EQUIPMENT MAGNET COVER
K970185 · Contour Fabricators, Inc. · Apr 1997
EYE TRAY
K970722 · Trinity Laboratories, Inc. · Mar 1997
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
K964142 · Medline Industries, Inc. · Feb 1997