Cleared Traditional

K941302 - STERILE IMPERVIOUS ORTHOPEDIC STOCKINETTE

K941302 is an FDA 510(k) clearance for STERILE IMPERVIOUS ORTHOPEDIC STOCKINETTE, manufactured by Cush Industries, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K941302 · Cush Industries, Inc. · General Hospital
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May 1994
Decision
56d
Days
Class 2
Risk

K941302 is an FDA 510(k) clearance for the STERILE IMPERVIOUS ORTHOPEDIC STOCKINETTE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Cush Industries, Inc. (Piney Flats, US). The FDA issued a Cleared decision on May 12, 1994 after a review of 56 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 Cush Industries, Inc. devices

FDA 510(k) Submission Details - K941302

510(k) Number K941302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1994
Decision Date May 12, 1994
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
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 286
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K941302.
SURGICAL DRAPES
K943122 · Mallinckrodt Group, Inc. · Sep 1994
GLOBAL SHOULDER O.R. DRAPE PACK
K941233 · Depuy, Inc. · Jul 1994
MEDSURG STERILE O.R. TOWELS
K940175 · Medsurg Industries, Inc. · May 1994
CONVERTORS OPTI-SORB DRAPE MATERIAL
K940702 · Baxter Healthcare Corp · Apr 1994
STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE
K924101 · Baxter Healthcare Corp · Apr 1994
STSTORZ DP5300 AND DP9502 STERILE DRAPES
K934445 · Storz Instrument Co. · Apr 1994