Cleared Traditional

K901465 - ABSORBABLE GAUZE DRAPE

K901465 is an FDA 510(k) clearance for ABSORBABLE GAUZE DRAPE, manufactured by Ulti-Med Intl., Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K901465 · Ulti-Med Intl., Inc. · General Hospital
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Jun 1990
Decision
77d
Days
Class 2
Risk

K901465 is an FDA 510(k) clearance for the ABSORBABLE GAUZE DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Ulti-Med Intl., Inc. (Glendale Hts., US). The FDA issued a Cleared decision on June 12, 1990 after a review of 77 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 Ulti-Med Intl., Inc. devices

FDA 510(k) Submission Details - K901465

510(k) Number K901465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1990
Decision Date June 12, 1990
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
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 249
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K901465.
CUSTOMED LAP PACK I
K902029 · Customed, Inc. · Jul 1990
CUSTOMED LAP PACK III
K902030 · Customed, Inc. · Jul 1990
CUSTOMED LAP PACK IV
K902031 · Customed, Inc. · Jul 1990
MERCY HIP/KNEE PACK
K896215 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
OR TOWEL PACKS
K894764 · Advance Medical Designs, Inc. · Aug 1989
THERMALAP
K893212 · O.R. Concepts, Inc. · Jun 1989