Cleared Traditional

K161232 - ON-Q* EchoSpark Echogenic Catheter (FDA 510(k) Clearance)

Also includes:
ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit

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

K161232 · Halyard Health · Anesthesiology device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 225d · This submission: 151d
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.