Cleared Traditional

K960803 - RX TEXTILES STERILE STOCKINETTE

K960803 is an FDA 510(k) clearance for RX TEXTILES STERILE STOCKINETTE, manufactured by Rx Textiles, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K960803 · Rx Textiles, Inc. · General Hospital
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Jul 1996
Decision
136d
Days
Class 2
Risk

K960803 is an FDA 510(k) clearance for the RX TEXTILES STERILE STOCKINETTE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Rx Textiles, Inc. (Monroe, US). The FDA issued a Cleared decision on July 12, 1996 after a review of 136 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 Rx Textiles, Inc. devices

FDA 510(k) Submission Details - K960803

510(k) Number K960803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1996
Decision Date July 12, 1996
Days to Decision 136 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
7d slower than avg
Panel avg: 129d · This submission: 136d
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 262
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K960803.
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
TEX-CARE STERILE STOCKINETTE
K955749 · Flynt Amtex, Inc. · Nov 1996
TUAT SPLATTER CONTROL SHIELD SCS-300
K962003 · Taut, Inc. · Jul 1996
ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE
K960045 · The Sewing Source, Inc. · Jun 1996
PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE
K954824 · Medical Creative Technologies, Inc. · Apr 1996
VOLMED OPERATION DRAPE
K955872 · Medal Intl. Sales Co., LLC · Mar 1996