Cleared Traditional

K083424 - BUSSE SURGICAL DRAPE

K083424 is an FDA 510(k) clearance for BUSSE SURGICAL DRAPE, manufactured by Busse Hosipital Disposables. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K083424 · Busse Hosipital Disposables · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
99d
Days
Class 2
Risk

K083424 is an FDA 510(k) clearance for the BUSSE SURGICAL DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Busse Hosipital Disposables (Hauppauge, US). The FDA issued a Cleared decision on February 26, 2009 after a review of 99 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.

FDA 510(k) Submission Details - K083424

510(k) Number K083424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2008
Decision Date February 26, 2009
Days to Decision 99 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
30d faster than avg
Panel avg: 129d · This submission: 99d
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 322
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K083424.
MRI NEURO DRAPE
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
BUSSE SURGICAL DRAPE
K082297 · Busse Hospital Disposables, Inc. · Dec 2008
SRI LP DRAPE
K080796 · Sri/Surgical Express · Nov 2008
PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS
K080629 · Promedical Products Co., Ltd. · Oct 2008