# K161232: ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit

- Pathway: 510(k) (Traditional)
- Applicant: Halyard Health
- Decided: Sep 30, 2016 after 151 days
- Product code: BSO (Catheter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K813186 (1981). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143164: ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set, Kimberly-Clark Corporation (2014) Summary page 5.
- K073187: Peripheral Nerve Block Support Tray, Life-Tech, Inc. (2008) Summary page 8.

## Indications for use
The ON-Q* EchoSpark* Echogenic Catheter is indicated for delivery of medication for regional anesthesia and pain management. Routes of administration may be perineural, intraoperative, or percutaneous. The ON-Q* EchoSpark*Echogenic Catheter is indicated for patients undergoing continuous regional anesthesia and pain management procedures. The ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is indicated for delivery of medication for regional anesthesia and pain management. Routes of administration may be perineural, intraoperative, or percutaneous. The ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is indicated for patients undergoing continuous regional anesthesia and pain management procedures.

Source page: https://510kreport.com/device/K161232
Methodology: https://510kreport.com/methodology