Cleared Traditional

B. Braun Tear-Away Introducer Needle (K171584) - FDA 510(k) Clearance

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

K171584 · B.Braun Medical, Inc. · Anesthesiology device
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Dec 2017
Decision
205d
Days
Class 2
Risk

K171584 is an FDA 510(k) clearance for the B. Braun Tear-Away Introducer Needle. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on December 22, 2017 after a review of 205 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5120 - 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 B.Braun Medical, Inc. devices

Submission Details

510(k) Number K171584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2017
Decision Date December 22, 2017
Days to Decision 205 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
65d slower than avg
Panel avg: 140d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSO Catheter, Conduction, Anesthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5120
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 - BSO Catheter, Conduction, Anesthetic

All 20
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K171584.
Medline Reinforced Epidural Catheter
K181782 · Medline Industries, Inc. · Mar 2019
EPINAUT
K173541 · Imedicom Co., Ltd. · Aug 2018
Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
K172777 · PAJUNK GmbH Medizintechnologie · May 2018
Perifix and Contiplex Catheter
K153297 · B.Braun Medical, Inc. · Aug 2016
Medline Epidural Catheter
K150731 · Medline Industries, Inc. · Mar 2016
PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.
K090884 · B.Braun Medical, Inc. · Jun 2009