Cleared Traditional

CONVERTORS DRAPE MATERIAL (K964125) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964125 · Allegiance Healthcare Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 1996
Decision
69d
Days
Class 2
Risk

K964125 is an FDA 510(k) clearance for the CONVERTORS DRAPE MATERIAL. 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 December 23, 1996 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Allegiance Healthcare Corp. devices

Submission Details

510(k) Number K964125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1996
Decision Date December 23, 1996
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 29
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K964125.
MEDLINE ASEP PLUS SURGICAL DRAPES
K023432 · Medline Industries, Inc. · Nov 2002
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
K994211 · Dentsply Intl. · Feb 2000
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
K964142 · Medline Industries, Inc. · Feb 1997
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
CONVERTORS ISO BAC DRAPE MATERIAL
K931267 · Baxter Healthcare Corp · Nov 1994
GLOBAL SHOULDER O.R. DRAPE PACK
K941233 · Depuy, Inc. · Jul 1994