Cleared Traditional

K945486 - SPLATTER CONTROL SHIELD

K945486 is the FDA 510(k) clearance for SPLATTER CONTROL SHIELD by Taut, Inc.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K945486 · Taut, Inc. · General Hospital
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Feb 1995
Decision
112d
Days
Class 2
Risk

K945486 is an FDA 510(k) clearance for the SPLATTER CONTROL SHIELD. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Taut, Inc. (Geneva, US). The FDA issued a Cleared decision on February 28, 1995 after a review of 112 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 Taut, Inc. devices

Submission Details

510(k) Number K945486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1994
Decision Date February 28, 1995
Days to Decision 112 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
17d faster than avg
Panel avg: 129d · This submission: 112d
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 154
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K945486.
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DEROYAL SURGICAL INSTRUMENT DRAPE
K950565 · Deroyal Industries, Inc. · Dec 1995
SURGICAL DRAPE KIT
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CONVERTORS ISO BAC DRAPE MATERIAL
K931267 · Baxter Healthcare Corp · Nov 1994
GLOBAL SHOULDER O.R. DRAPE PACK
K941233 · Depuy, Inc. · Jul 1994
MEDSURG STERILE O.R. TOWELS
K940175 · Medsurg Industries, Inc. · May 1994