Cleared Traditional

K940175 - MEDSURG STERILE O.R. TOWELS

K940175 is an FDA 510(k) clearance for MEDSURG STERILE O.R. TOWELS, manufactured by Medsurg Industries, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K940175 · Medsurg Industries, Inc. · General Hospital
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May 1994
Decision
135d
Days
Class 2
Risk

K940175 is an FDA 510(k) clearance for the MEDSURG STERILE O.R. TOWELS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on May 26, 1994 after a review of 135 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 Medsurg Industries, Inc. devices

FDA 510(k) Submission Details - K940175

510(k) Number K940175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1994
Decision Date May 26, 1994
Days to Decision 135 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 129d · This submission: 135d
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 225
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K940175.
CONVERTORS ISO BAC DRAPE MATERIAL
K931267 · Baxter Healthcare Corp · Nov 1994
SURGICAL DRAPES
K943122 · Mallinckrodt Group, Inc. · Sep 1994
GLOBAL SHOULDER O.R. DRAPE PACK
K941233 · Depuy, Inc. · Jul 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