Cleared Special

K073222 - MODIFICATION TO:SPECIALTY NEEDLES (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K073222 · Busse Hospital Disposables, Inc. · Anesthesiology device
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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.

View all Busse Hospital Disposables, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 139d · This submission: 146d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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)

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