Cleared Traditional

K913506 - CONVERTORS SAFECARE GOWN & DRAPE MATERIAL

K913506 is the FDA 510(k) clearance for CONVERTORS SAFECARE GOWN & DRAPE MATERIAL by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K913506 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
65d
Days
Class 2
Risk

K913506 is an FDA 510(k) clearance for the CONVERTORS SAFECARE GOWN & DRAPE MATERIAL. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Waukegan, US). The FDA issued a Cleared decision on October 11, 1991 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K913506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1991
Decision Date October 11, 1991
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
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 159
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K913506.
QUALTEX SURGICAL DRAPE, MODIFICATION
K913486 · Deroyal Industries, Inc. · Feb 1992
ARTHROSCOPY CAMERA DRAPE
K915214 · O.R. Concepts, Inc. · Jan 1992
QUALTEX MAGNETIC INSTRUMENT DRAPE
K914369 · Deroyal Industries, Inc. · Dec 1991
CUSTOM PROCEDURE TRAY
K911565 · Vanguard Medical Concepts, Inc. · Aug 1991
QUALTEX SURGICAL DRAPE
K910495 · Deroyal Industries, Inc. · Feb 1991
CUSTOMED CARDIOVASCULAR PACK
K904693 · Customed, Inc. · Jan 1991