Cleared Traditional

K942228 - OREX O.R. TOWEL

K942228 is an FDA 510(k) clearance for OREX O.R. TOWEL, manufactured by Thantex Specialties, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K942228 · Thantex Specialties, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
228d
Days
Class 2
Risk

K942228 is an FDA 510(k) clearance for the OREX O.R. TOWEL. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Thantex Specialties, Inc. (Asheville, US). The FDA issued a Cleared decision on December 20, 1994 after a review of 228 days - an extended review 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: 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 Thantex Specialties, Inc. devices

FDA 510(k) Submission Details - K942228

510(k) Number K942228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1994
Decision Date December 20, 1994
Days to Decision 228 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
99d slower than avg
Panel avg: 129d · This submission: 228d
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 191
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K942228.
3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS
K946024 · 3M Healthcare · Feb 1995
CIVCO PROBE BOOT/CORD COVER
K943393 · CIVCO Medical Instruments Co., Inc. · Feb 1995
3M X-LARGE SHEET #7979/ #7979NS
K946025 · 3M Healthcare · Feb 1995
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