Cleared Special

K073222 - MODIFICATION TO:SPECIALTY NEEDLES

K073222 is an FDA 510(k) clearance for MODIFICATION TO:SPECIALTY NEEDLES, manufactured by Busse Hospital Disposables, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Special 510(k) pathway after a 146-day FDA review.

K073222 · Busse Hospital Disposables, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
146d
Days
Class 2
Risk

K073222 is an FDA 510(k) clearance for the MODIFICATION TO:SPECIALTY NEEDLES. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Busse Hospital Disposables, Inc. (Hauppauge, US). The FDA issued a Cleared decision on April 9, 2008 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - the FDA anesthesiology and respiratory 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. Standard predicate reliance. 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 - K073222

510(k) Number K073222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2007
Decision Date April 09, 2008
Days to Decision 146 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 140d · This submission: 146d
Pathway characteristics
Modification to existing cleared device.

BSP Device Classification - Class 2, Special Controls

Product Code BSP Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5150
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 - BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 151
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K073222 · MODIFICATION TO:SPECIALTY NEEDLES
Download PDF FDA Summary Busse Hospital Dispos…