Cleared Traditional

K131006 - ANESTHESIA CONDUCTION NEEDLES

K131006 is an FDA 510(k) clearance for ANESTHESIA CONDUCTION NEEDLES, manufactured by Lccs Products Limited. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K131006 · Lccs Products Limited · Anesthesiology device
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Dec 2013
Decision
239d
Days
Class 2
Risk

K131006 is an FDA 510(k) clearance for the ANESTHESIA CONDUCTION NEEDLES. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Lccs Products Limited (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on December 6, 2013 after a review of 239 days - an extended review cycle.

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 Lccs Products Limited devices

FDA 510(k) Submission Details - K131006

510(k) Number K131006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2013
Decision Date December 06, 2013
Days to Decision 239 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
99d slower than avg
Panel avg: 140d · This submission: 239d
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 104
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K131006.
UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle
K142553 · Unisis Corp. · Jan 2015
UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE
K141126 · Unisis Corp. · Oct 2014
PERICAN ULTRA
K133632 · B.Braun Medical, Inc. · Jun 2014
SONIXGPS
K121812 · Ultrasonix Medical Corporation · Dec 2013
ANESTHESIA CONDUCTION NEEDLES
K120475 · Shanghai Samedical & Plastic Instruments Co., Ltd. · Dec 2012
CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE
K121846 · B.Braun Medical, Inc. · Nov 2012