Cleared Traditional

K955749 - TEX-CARE STERILE STOCKINETTE

K955749 is an FDA 510(k) clearance for TEX-CARE STERILE STOCKINETTE, manufactured by Flynt Amtex, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K955749 · Flynt Amtex, Inc. · General Hospital
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Nov 1996
Decision
339d
Days
Class 2
Risk

K955749 is an FDA 510(k) clearance for the TEX-CARE STERILE STOCKINETTE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Flynt Amtex, Inc. (Burlington, US). The FDA issued a Cleared decision on November 22, 1996 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Flynt Amtex, Inc. devices

FDA 510(k) Submission Details - K955749

510(k) Number K955749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1995
Decision Date November 22, 1996
Days to Decision 339 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 129d · This submission: 339d
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 K955749.
THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE
K963675 · Micro-Medical Devices, Inc. · Jan 1997
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K964125 · Allegiance Healthcare Corp. · Dec 1996
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
TUAT SPLATTER CONTROL SHIELD SCS-300
K962003 · Taut, Inc. · Jul 1996
RX TEXTILES STERILE STOCKINETTE
K960803 · Rx Textiles, Inc. · Jul 1996
ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE
K960045 · The Sewing Source, Inc. · Jun 1996