510(k) · Cleared
Recalled · 2008I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, 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 Sep 9, 2005 as substantially equivalent to K040337 (I-Flow Corp., 2004) after a 36-day review. Its family tree reaches back 1 generation to 2004. 1 of the 11 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 9, 2005
- Review
- 36 days
- Class
- Class II
- Product code
- MEB
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040337 (2004). 9 later devices descend from it, 3 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK040337 I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump)I-Flow Corp. · 2004
- This deviceK052117 I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump…I-Flow Corp. · 2005
- Descendant · cites it directly · 4 of its ownK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Recalled (Class I)
- Descendant · cites it directly · 3 of its ownK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
- Descendant · cites it directly · 3 of its ownK063530 ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump…I-Flow Corp. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK240624 InfuLifeFirst Medical Source, LLC · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K081905 Accuflow and Accuflux Elastomeric Infusion Pumpcites it directly · 2008
Most influential descendants
Showing 5 of 9 · See all- K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · cites it directly4descendants
- K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016 · cites it directly3descendants
- K063530ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step…I-Flow Corp. · 2007 · cites it directly3descendants
- K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026 · 2 generations on0descendants
- K240624InfuLifeFirst Medical Source, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040337 | I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump) | I-Flow Corp. | 2004 | — |
| 0 (this device) | K052117 | I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump) | I-Flow Corp. | 2005 | — |
| +1 | K081905 | Accuflow and Accuflux Elastomeric Infusion Pump | Westmed, Inc. | 2008 | Class I |
| +1 | K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte., Ltd. | 2016 | — |
| +1 | K063530 | ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse… | I-Flow Corp. | 2007 | 3 |
| +2 | K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte., Ltd. | 2026 | — |
| +2 | K240624 | InfuLife | First Medical Source, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 1 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K040337 | I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump)Summary page 1…Elastomeric Pump Common Name: Infusion Pump and Administration Set Classification Name: Pump, Infusion Existing Device: I-Flow Elastomeric Pump (K040337) Device Description: The I-Flow ElastomericPump consists of an elastomeric pressure source with an i… | 2004 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 11, 2008 | Not classified | Z-2111-2009 | Labeling mix-ups | I-Flow Corporation received two complaints involving Easypump LT 60-24 (Lot 612996) containing a 100 ml x 2 ml/hr pump in the sterile package instead of a 60 ml x 2 ml/hr pump (Illustration was included to show consignee what both the… |
| Jan 17, 2006 | Not classified | Z-0584-06 | Other | The sterile pack may contain the wrong infusion pump inside. |
| Jan 17, 2006 | Not classified | Z-0585-06 | Other | The sterile pack may contain the wrong infusion pump inside. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All MEB devicesMEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural. 2. The I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics)…
Read the full statement (123 words)
1. The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
2. The I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to 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 or percutaneous.
3. The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to 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/K052117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052117: I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052117
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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