510(k) · Cleared
Recalled · Class I · 2012I-Flow Elastomeric Pump with Bolus
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 Oct 18, 2002 as substantially equivalent to K020862 (I-Flow Corp., 2002) after a 14-day review. Its family tree reaches back 5 generations to 1990. 1 of the 15 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Oct 18, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- MEB
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 5 generations to K896422 (1990). 14 ancestors in all, the oldest K884505 (1989). No later device cites it as a predicate yet. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 4 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 3 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 2 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 1 generation backK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
- This deviceK023318 I-Flow Elastomeric Pump with BolusI-Flow Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −4 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −3 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −2 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −1 | K020862 | I-Flow Elastomeric Pump | I-Flow Corp. | 2002 | 1 |
| 0 (this device) | K023318 | I-Flow Elastomeric Pump with Bolus | I-Flow Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 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 |
|---|---|---|---|
| * | K020862 | I-Flow Elastomeric PumpSummary page 1…ON-Q, PainBuster, C-bloc, Eclipse, C-Series, Easypump, Homepump Classification Name: Pump, Infusion, Elastomeric Existing Devii; I-Flow Elastomeric Pump (K020862) Device Description: This special 51O(k) proposes a new optional component for the I-Flow Elastomeric… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2012 | Class I | Z-2253-2012 | Device Design | It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. As a result, the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 7 months on median.
- 4 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K020862.
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 1-Flow Elastomeric Pump with Bolus 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, subcutaneous, intramuscular and epidural.
2 The I-Flow Elastomeric Pump with Bolus 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023318 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023318: I-Flow Elastomeric Pump with Bolus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023318
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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