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
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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 175
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K970554.
CONVERTORS TRILAMINATE DRAPES
K981818 · Allegiance Healthcare Corp. · Jul 1998
PROMAX SURGICAL DRAPES AND COVERS
K980183 · Standard Textile Co., Inc. · Feb 1998
FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
K974647 · Customed, Inc. · Jan 1998
EYE TRAY
K970722 · Trinity Laboratories, Inc. · Mar 1997
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
K964142 · Medline Industries, Inc. · Feb 1997
CONVERTORS DRAPE MATERIAL
K964125 · Allegiance Healthcare Corp. · Dec 1996