# K181360: ON-Q* Pump with Bolus

- Pathway: 510(k) (Traditional)
- Applicant: Halyard Health
- Decided: Mar 22, 2019 after 304 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K040337 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063530: ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step Kvo, Easypump, I-Flow Corp. (2007) Summary page 4.

## Indications for use
ON-Q* Pump is intended to provide continuous delivery of medication (such as local anesthetics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and/or pain management. Routes of administration include: intraoperative site, peripheral nerve block, percutaneous and epidural. ON-Q* Pump is indicated to significantly decrease pain and narcotic use when used to deliver local anesthetics to or around surgical wound sites, or close proximity to nerves, when compared to narcotic only pain management. ON-Q* Pump with Bolus device is intended for users 18 years of age and older.

Source page: https://510kreport.com/device/K181360
Methodology: https://510kreport.com/methodology