Cleared Traditional

CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 (K100241) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100241 · B.Braun Medical, Inc. · Anesthesiology device
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Apr 2010
Decision
79d
Days
Class 2
Risk

K100241 is an FDA 510(k) clearance for the CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on April 16, 2010 after a review of 79 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all B.Braun Medical, Inc. devices

Submission Details

510(k) Number K100241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2010
Decision Date April 16, 2010
Days to Decision 79 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
61d faster than avg
Panel avg: 140d · This submission: 79d
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 43
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K100241.
PENCAN SPINAL NEEDLE
K112515 · B.Braun Medical, Inc. · Dec 2011
MEDLINE EPIDURAL AND SPINAL NEEDLES
K110194 · Medline Industries, Inc. · Jun 2011
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
K101728 · Cook, Inc. · Aug 2010
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
K093209 · Cook, Inc. · Feb 2010
BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
K081446 · Becton, Dickinson & CO · Jul 2008
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
K030618 · Wilson-Cook Medical, Inc. · May 2003