Cleared Traditional

K924101 - STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE

K924101 is an FDA 510(k) clearance for STERILE CONVERTORS SMS POLYPROPYLENE GO..., manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 606-day FDA review.

K924101 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
606d
Days
Class 2
Risk

K924101 is an FDA 510(k) clearance for the STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE. 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 April 11, 1994 after a review of 606 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

FDA 510(k) Submission Details - K924101

510(k) Number K924101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1992
Decision Date April 11, 1994
Days to Decision 606 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
477d slower than avg
Panel avg: 129d · This submission: 606d
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 449
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K924101.
SURGICAL DRAPE
K931418 · Custom Medical Products, Ltd. · May 1994
HEAD SHEET
K931455 · Custom Medical Products, Ltd. · May 1994
CONVERTORS OPTI-SORB DRAPE MATERIAL
K940702 · Baxter Healthcare Corp · Apr 1994
STSTORZ DP5300 AND DP9502 STERILE DRAPES
K934445 · Storz Instrument Co. · Apr 1994
CONTAIN-OR
K934215 · Dlp, Inc. · Feb 1994
DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252
K931091 · Alliance Medical, Inc. · Feb 1994
K924101 · STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE
Download PDF FDA Summary Baxter Healthcare Corp