510(k) · Cleared
Recalled · 2011ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step Kvo, Easypump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Flow Corp. · MEB Pump, Infusion, Elastomeric
Cleared on Jan 26, 2007 as substantially equivalent to K052117 (I-Flow Corp., 2005) after a 65-day review. Its family tree reaches back 2 generations to 2004. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 26, 2007
- Review
- 65 days
- Class
- Class II
- Product code
- MEB
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K040337 (2004). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK040337 I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump)I-Flow Corp. · 2004
- 1 generation backK052117 I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump…I-Flow Corp. · 2005 · Recalled
- This deviceK063530 ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump…I-Flow Corp. · 2007
- Descendant · cites it directly · 0 of its ownK181360 ON-Q* Pump with BolusHalyard Health · 2019
- Descendant · cites it directly · 0 of its ownK131247 Multibolus II Disposable Pain Management SystemMfs - Medical Flow Systems, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK072053 Smartblock Pain PumpMedical Flow Systems, Ltd. · 2007 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040337 | I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump) | I-Flow Corp. | 2004 | — |
| −1 | K052117 | I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump) | I-Flow Corp. | 2005 | 3 |
| 0 (this device) | K063530 | ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse… | I-Flow Corp. | 2007 | — |
| +1 | K181360 | ON-Q* Pump with Bolus | Halyard Health | 2019 | — |
| +1 | K131247 | Multibolus II Disposable Pain Management System | Mfs - Medical Flow Systems, Ltd. | 2013 | — |
| +1 | K072053 | Smartblock Pain Pump | Medical Flow Systems, Ltd. | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
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 |
|---|---|---|---|
| * | K052117 | I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump)Summary page 1…Pump with Select-A-Flow, ON-O Pump with OnDemand Common Name: Elastomeric Infusion Pump Existing Device: I-Flow Elastomeric Pump (K052117) Design Change: This Special 510(k) submission proposes an increase in the maximum fill volume fro… | 2005 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 15, 2011 | Not classified | Z-2860-2011 | Process control | The recall was initiated because I Flow became aware that a small percentage of ON-Q Pump with Select A Flow may develop a minor leak with a flow rate controller. There may be consequences for the patient, such as under delivery of pain… |
| Feb 14, 2008 | Not classified | Z-2133-2008 | Labeling design | Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label. |
| Feb 12, 2008 | Not classified | Z-1869-2008 | Other | The ON-Q PainBuster, REF PS6504 (lot number 772166), box may contain the wrong product, ON-Q PainBuster, REF PS6502. If the wrong product is used, patients would receive a 2 ml/hr infusion rather than a 5 ml/hr infusion, which could… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K181360 (Halyard Health, 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K052117.
How does its category compare?
All MEB devicesMEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
1. The ON-Q Pump is intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.
2. The ON-Q Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063530 · printed Nov 3, 2026
Cite this page
510(k) Report. “K063530: ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step Kvo, Easypump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K063530
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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