Cleared Special

K092212 - BUSSE SURGICAL DRAPES III

K092212 is an FDA 510(k) clearance for BUSSE SURGICAL DRAPES III, manufactured by Busse Hospital Disposables, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Special 510(k) pathway after a 79-day FDA review.

K092212 · Busse Hospital Disposables, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
79d
Days
Class 2
Risk

K092212 is an FDA 510(k) clearance for the BUSSE SURGICAL DRAPES III. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Busse Hospital Disposables, Inc. (Hauppauge, US). The FDA issued a Cleared decision on October 9, 2009 after a review of 79 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K092212

510(k) Number K092212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2009
Decision Date October 09, 2009
Days to Decision 79 days
Submission Type Special
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
50d faster than avg
Panel avg: 129d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

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 K092212.
EMM EQUIPMENT COVER-POLYTHYLENE
K101689 · Exact Medical Manufacturing, Inc. · Sep 2010
BUSSE SURGICAL DRAPES IV
K093909 · Busse Hospital Disposables, Inc. · May 2010
IMC SURGICAL DRAPE
K100208 · International Medsurg Connection · Apr 2010
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K091343 · Surgivision, Inc. · Sep 2009
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
K083234 · Kimberly-Clark Corp. · Mar 2009
DUKAL SURGICAL DRAPE
K083320 · Dukal Corp. · Mar 2009
K092212 · BUSSE SURGICAL DRAPES III
Download PDF FDA Summary Busse Hospital Dispos…