Cleared Abbreviated

K081446 - BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237

K081446 is an FDA 510(k) clearance for BD SPINAL NEEDLE, manufactured by Becton, Dickinson & CO. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Abbreviated 510(k) pathway after a 56-day FDA review.

K081446 · Becton, Dickinson & CO · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
56d
Days
Class 2
Risk

K081446 is an FDA 510(k) clearance for the BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (Franklin Lakes, US). The FDA issued a Cleared decision on July 17, 2008 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Becton, Dickinson & CO devices

FDA 510(k) Submission Details - K081446

510(k) Number K081446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2008
Decision Date July 17, 2008
Days to Decision 56 days
Submission Type Abbreviated
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
84d faster than avg
Panel avg: 140d · This submission: 56d
Pathway characteristics
Standards-based clearance path.

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 122
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K081446.
STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150
K082772 · Life-Tech, Inc. · Feb 2009
PROLONG
K081864 · Life-Tech, Inc. · Sep 2008
HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
K080603 · Te ME NA Sas · Aug 2008
LAURIMED SPINAL INJECTION SYSTEM
K080140 · Laurimed, LLC · May 2008
MODIFICATION TO:SPECIALTY NEEDLES
K073222 · Busse Hospital Disposables, Inc. · Apr 2008
DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR
K073516 · Kyphon, Inc. · Feb 2008