Cleared Traditional

K905803 - HALE SUN SURGICAL TOWEL OR O.R. TOWEL

K905803 is an FDA 510(k) clearance for HALE SUN SURGICAL TOWEL OR O.R. TOWEL, manufactured by Hale Sun Industries, Ltd.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K905803 · Hale Sun Industries, Ltd. · General Hospital
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May 1991
Decision
144d
Days
Class 2
Risk

K905803 is an FDA 510(k) clearance for the HALE SUN SURGICAL TOWEL OR O.R. TOWEL. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Hale Sun Industries, Ltd. (Providence, US). The FDA issued a Cleared decision on May 21, 1991 after a review of 144 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 Hale Sun Industries, Ltd. devices

FDA 510(k) Submission Details - K905803

510(k) Number K905803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1990
Decision Date May 21, 1991
Days to Decision 144 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 129d · This submission: 144d
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 290
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K905803.
CUSTOM PROCEDURE TRAY
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QUALTEX SURGICAL DRAPE
K910495 · Deroyal Industries, Inc. · Feb 1991
CUSTOMED CARDIOVASCULAR PACK
K904693 · Customed, Inc. · Jan 1991
CUSTOMED ANGIODRAPE PACK FEMORAL
K904694 · Customed, Inc. · Jan 1991