Cleared Traditional

K080140 - LAURIMED SPINAL INJECTION SYSTEM

K080140 is an FDA 510(k) clearance for LAURIMED SPINAL INJECTION SYSTEM, manufactured by Laurimed, LLC. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K080140 · Laurimed, LLC · Anesthesiology device
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May 2008
Decision
108d
Days
Class 2
Risk

K080140 is an FDA 510(k) clearance for the LAURIMED SPINAL INJECTION SYSTEM. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Laurimed, LLC (Redwood City, US). The FDA issued a Cleared decision on May 9, 2008 after a review of 108 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. 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.

View all Laurimed, LLC devices

FDA 510(k) Submission Details - K080140

510(k) Number K080140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2008
Decision Date May 09, 2008
Days to Decision 108 days
Submission Type Traditional
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
32d faster than avg
Panel avg: 140d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 118
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K080140.
PROLONG
K081864 · Life-Tech, Inc. · Sep 2008
HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
K080603 · Te ME NA Sas · Aug 2008
BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
K081446 · Becton, Dickinson & CO · Jul 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
RK EPIDURAL NEEDLE
K072005 · Epimed International · Feb 2008