510(k) · Cleared
ClearedInfuLife
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
First Medical Source, LLC · MEB Pump, Infusion, Elastomeric
Cleared on Nov 5, 2024 as substantially equivalent to K151650 (Epic Medical Pte., Ltd., 2016) after a 245-day review. Its family tree reaches back 12 generations to 1990. 1 of the 49 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 5, 2024
- Review
- 245 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K896422 (1990). 48 ancestors in all, the oldest K802820 (1980). No later device cites it as a predicate yet. 1 of the 49 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 8 generations between
- 3 generations backK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
- 2 generations backK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Recalled (Class I)
- 1 generation backK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
- This deviceK240624 InfuLifeFirst Medical Source, LLC · 2024
Show all 12 generations
- Root · 12 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 11 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 10 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 9 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 8 generations backK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
- 7 generations backK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
- 6 generations backK032642 Beeline SystemMckinley, Inc. · 2003
- 5 generations backK042228 Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004
- 4 generations backK050770 Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005
- 3 generations backK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
- 2 generations backK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Recalled (Class I)
- 1 generation backK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
- This deviceK240624 InfuLifeFirst Medical Source, LLC · 2024
Class I recalls in this family
- K081905 Accuflow and Accuflux Elastomeric Infusion Pump2 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −11 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −10 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −9 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −8 | K020862 | I-Flow Elastomeric Pump | I-Flow Corp. | 2002 | 1 |
| −7 | K023098 | Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit | Mckinley Infuser | 2002 | — |
| −6 | K032642 | Beeline System | Mckinley, Inc. | 2003 | — |
| −5 | K042228 | Beeline Motiv, Propolis, Pca | Mckinley, Inc. | 2004 | — |
| −4 | K050770 | Modification to Accufuser, Accufuser Plus Standard Procedure Kit | Mckinley Medical, LLC | 2005 | — |
| −3 | K052451 | MPS Acacia Medflo Elastomeric Pump | Mps Acacia | 2005 | — |
| −2 | K081905 | Accuflow and Accuflux Elastomeric Infusion Pump | Westmed, Inc. | 2008 | Class I |
| −1 | K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte., Ltd. | 2016 | — |
| 0 (this device) | K240624 | InfuLife | First Medical Source, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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
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 |
|---|---|---|---|
| * | K151650 | SMARTez elastomeric infusion pumpSummary page 6…ification: 880.5725 Product Code: MEB, FRN Class: II Device Panel: General Hospital Predicate Device: K151650 Common/Usual Name: Elastomeric Infusion pump Trade/Proprietary Name: SMARTeZ elastomeric infusion pump Class… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 9 companies; a new generation was cleared every 1.1 years on median.
- 12 of the 48 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K151650.
How does its category compare?
All MEB devicesMEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
InfuLife is a single-use, sterile, disposable elastomeric infusion pump intended for continuous and/or intermittent infusion of medications for general infusion at home, in a hospital, or in alternate sites. InfuLife is indicated for delivery of antibiotics, chemotherapy, and pain management, as directed by a physician or licensed healthcare professional. Routes of administration include intravenous, intra-arterial, subcutaneous, intramuscular, and…
Read the full statement (108 words)
InfuLife is a single-use, sterile, disposable elastomeric infusion pump intended for continuous and/or intermittent infusion of medications for general infusion at home, in a hospital, or in alternate sites. InfuLife is indicated for delivery of antibiotics, chemotherapy, and pain management, as directed by a physician or licensed healthcare professional. Routes of administration include intravenous, intra-arterial, subcutaneous, intramuscular, and epidural. Additionally, InfuLife is indicated for continuous and/or intermittent delivery of medication, such as local anesthetics or narcotics, to surgical wound sites and/or proximity to nerves for preoperative, perioperative, and postoperative regional anesthesia and pain management. InfuLife is intended for use by physicians, clinicians, pharmacists, and other licensed healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240624 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240624: InfuLife.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240624
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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