510(k) · Cleared
ClearedON-Q* Pump with Bolus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Halyard Health · MEB Pump, Infusion, Elastomeric
Cleared on Mar 22, 2019 as substantially equivalent to K063530 (I-Flow Corp., 2007) after a 304-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Mar 22, 2019
- Review
- 304 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040337 (2004). No later device cites it as a predicate yet.
- Root · 3 generations backK040337 I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump)I-Flow Corp. · 2004
- 2 generations backK052117 I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump…I-Flow Corp. · 2005 · Recalled
- 1 generation backK063530 ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump…I-Flow Corp. · 2007 · Recalled
- This deviceK181360 ON-Q* Pump with BolusHalyard Health · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040337 | I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump) | I-Flow Corp. | 2004 | — |
| −2 | K052117 | I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump) | I-Flow Corp. | 2005 | 3 |
| −1 | K063530 | ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse… | I-Flow Corp. | 2007 | 3 |
| 0 (this device) | K181360 | ON-Q* Pump with Bolus | Halyard Health | 2019 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MEB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MEB device
- #1 K250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)score 14.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063530 | ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step…Summary page 4…Regulation Number: 21 CFR 880.5725 Product Code: MEB Device Class: Class II Primary Predicate Device: K063530, ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO,… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K063530.
How does its category compare?
All MEB devicesMEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MEB
42in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEB
17in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MEB
1,408in 2025
MAUDE reports naming product code MEB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 42 | 1 | 110 |
| 2008 | 2 | — | 3 | 444 |
| 2009 | 1 | — | 48 | 798 |
| 2010 | 0 | — | 2 | 1,827 |
| 2011 | 0 | — | 8 (1) | 2,265 |
| 2012 | 0 | — | 0 | 1,976 |
| 2013 | 1 | — | 2 (1) | 1,956 |
| 2014 | 1 | — | 0 | 2,695 |
| 2015 | 0 | — | 0 | 2,980 |
| 2016 | 1 | — | 0 | 2,147 |
| 2017 | 0 | — | 0 | 1,653 |
| 2018 | 0 | — | 17 | 1,473 |
| 2019 | 1 | — | 0 | 974 |
| 2020 | 0 | — | 0 | 2,732 |
| 2021 | 0 | — | 0 | 1,802 |
| 2022 | 0 | — | 0 | 1,288 |
| 2023 | 0 | — | 0 | 1,248 |
| 2024 | 2 | — | 0 | 1,424 |
| 2025 | 0 | — | 0 | 1,408 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181360: ON-Q* Pump with Bolus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181360
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026