Cleared Traditional

K093920 - BUSSE EPIDURAL CATHETER KIT

K093920 is an FDA 510(k) clearance for BUSSE EPIDURAL CATHETER KIT, manufactured by Busse Hospital Disposables. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K093920 · Busse Hospital Disposables · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
227d
Days
Class 2
Risk

K093920 is an FDA 510(k) clearance for the BUSSE EPIDURAL CATHETER KIT. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Busse Hospital Disposables (Hauppauge, US). The FDA issued a Cleared decision on August 6, 2010 after a review of 227 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5120 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K093920

510(k) Number K093920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2009
Decision Date August 06, 2010
Days to Decision 227 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 140d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSO Device Classification - Class 2, Special Controls

Product Code BSO Catheter, Conduction, Anesthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5120
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BSO Catheter, Conduction, Anesthetic

All 70
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K093920.
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K090884 · B.Braun Medical, Inc. · Jun 2009
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