Cleared Traditional

K962205 - STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE

K962205 is an FDA 510(k) clearance for STERILE AND NON-STERILE O.R. TOWELS, manufactured by Medline Industries, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K962205 · Medline Industries, Inc. · General Hospital
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Nov 1996
Decision
172d
Days
Class 2
Risk

K962205 is an FDA 510(k) clearance for the STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE.... Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on November 26, 1996 after a review of 172 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 Medline Industries, Inc. devices

FDA 510(k) Submission Details - K962205

510(k) Number K962205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1996
Decision Date November 26, 1996
Days to Decision 172 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
43d slower than avg
Panel avg: 129d · This submission: 172d
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 K962205.
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
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CONVERTORS DRAPE MATERIAL
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TEX-CARE STERILE STOCKINETTE
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TUAT SPLATTER CONTROL SHIELD SCS-300
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RX TEXTILES STERILE STOCKINETTE
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