Cleared Traditional

K944859 - OREX SURGICAL DRAPES

K944859 is an FDA 510(k) clearance for OREX SURGICAL DRAPES, 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 148-day FDA review.

K944859 · Thantex Specialties, Inc. · General Hospital
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Feb 1995
Decision
148d
Days
Class 2
Risk

K944859 is an FDA 510(k) clearance for the OREX SURGICAL DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Thantex Specialties, Inc. (Herndon, US). The FDA issued a Cleared decision on February 28, 1995 after a review of 148 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 Thantex Specialties, Inc. devices

FDA 510(k) Submission Details - K944859

510(k) Number K944859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1994
Decision Date February 28, 1995
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
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 K944859.
DEROYAL SURGICAL INSTRUMENT DRAPE
K950565 · Deroyal Industries, Inc. · Dec 1995
SURGICAL DRAPE KIT
K933148 · Nobelpharma USA, Inc. · Jun 1995
OREX(R) O.R EQUIPMENT DRAPES
K945755 · Thantex Specialties, Inc. · May 1995
COMPEL SURGICALDRAPES
K944863 · Standard Textile Co., Inc. · Feb 1995
3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS
K946024 · 3M Healthcare · Feb 1995
CIVCO PROBE BOOT/CORD COVER
K943393 · CIVCO Medical Instruments Co., Inc. · Feb 1995