Cleared Traditional

K131006 - ANESTHESIA CONDUCTION NEEDLES

K131006 is the FDA 510(k) clearance for ANESTHESIA CONDUCTION NEEDLES by Lccs Products Limited. It is a Class 2 Anesthesiology device (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

Submission Details

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
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.

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)

All 65
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