Cleared Traditional

K915740 - DISPOSABLE O.R. TOWEL

K915740 is the FDA 510(k) clearance for DISPOSABLE O.R. TOWEL by American Threshold Industries, Inc.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K915740 · American Threshold Industries, Inc. · General Hospital
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Jun 1992
Decision
182d
Days
Class 2
Risk

K915740 is an FDA 510(k) clearance for the DISPOSABLE O.R. TOWEL, STERILE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by American Threshold Industries, Inc. (Enka, US). The FDA issued a Cleared decision on June 22, 1992 after a review of 182 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 American Threshold Industries, Inc. devices

Submission Details

510(k) Number K915740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1991
Decision Date June 22, 1992
Days to Decision 182 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 129d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 160
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K915740.
DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE
K921204 · Trinity Laboratories, Inc. · Aug 1992
DRESSING CHANGE TRAY, STERILE, DISPOSABLE
K921394 · Trinity Laboratories, Inc. · Aug 1992
QUALTEX TUBE/CORD ORGANIZER
K921350 · Deroyal Industries, Inc. · Aug 1992
BARRIER DRAPE SHEET WITH SYMETRY FABRIC
K920995 · Johnson & Johnson Medical, Inc. · May 1992
MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP
K920517 · Trinity Laboratories, Inc. · May 1992
QUALTEX SURGICAL DRAPE, MODIFICATION
K913486 · Deroyal Industries, Inc. · Feb 1992