Cleared Traditional

K161232 - ON-Q* EchoSpark Echogenic Catheter

Also marketed or referenced as:
ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit

K161232 is an FDA 510(k) clearance for ON-Q* EchoSpark Echogenic Catheter, manufactured by Halyard Health. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K161232 · Halyard Health · Anesthesiology device
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Sep 2016
Decision
151d
Days
Class 2
Risk

K161232 is an FDA 510(k) clearance for the ON-Q* EchoSpark Echogenic Catheter. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Halyard Health (Alpharetta, US). The FDA issued a Cleared decision on September 30, 2016 after a review of 151 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 Halyard Health devices

FDA 510(k) Submission Details - K161232

510(k) Number K161232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2016
Decision Date September 30, 2016
Days to Decision 151 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
11d slower than avg
Panel avg: 140d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSO Device Classification - Class 2, Special Controls

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 61
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K161232.
B. Braun Tear-Away Introducer Needle
K171584 · B.Braun Medical, Inc. · Dec 2017
Certa Catheter
K171193 · Ferrosan Medical Devices Sp. Z.O.O. · Dec 2017
UltraCath Continuous Nerve block Catheter
K162522 · Teleflexmedical, Inc. · Mar 2017
Perifix and Contiplex Catheter
K153297 · B.Braun Medical, Inc. · Aug 2016
E-Cath
K152952 · PAJUNK GmbH Medizintechnologie · Jul 2016
Medline Epidural Catheter
K150731 · Medline Industries, Inc. · Mar 2016