510(k) · Cleared
ClearedMPS Acacia Medflo Elastomeric Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mps Acacia · MEB Pump, Infusion, Elastomeric
Cleared on Dec 8, 2005 as substantially equivalent to K011117 (Mps Acacia, 2001) and 3 other predicates after a 92-day review. Its family tree reaches back 9 generations to 1990. 1 of the 39 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Dec 8, 2005
- Review
- 92 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K896422 (1990). 33 ancestors in all, the oldest K890489 (1989). 5 later devices descend from it, 1 citing it directly. 1 of the 39 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 5 generations between
- 3 generations backK032642 Beeline SystemMckinley, Inc. · 2003
- 2 generations backK042228 Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004
- 1 generation backK050770 Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005
- This deviceK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
- Descendant · cites it directly · 4 of its ownK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK240624 InfuLifeFirst Medical Source, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK242152 SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd. · 2024
Show all 9 generations
- Root · 9 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 8 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 7 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 6 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 5 generations backK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
- 4 generations backK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
- 3 generations backK032642 Beeline SystemMckinley, Inc. · 2003
- 2 generations backK042228 Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004
- 1 generation backK050770 Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005
- This deviceK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
Class I recalls in this family
- K081905 Accuflow and Accuflux Elastomeric Infusion Pumpcites it directly · 2008
Most influential descendants
Showing 5 of 5 · See all- K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · cites it directly4descendants
- K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016 · 2 generations on3descendants
- K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026 · 3 generations on0descendants
- K240624InfuLifeFirst Medical Source, LLC · 2024 · 3 generations on0descendants
- K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −8 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −7 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −6 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −5 | K020862 | I-Flow Elastomeric Pump | I-Flow Corp. | 2002 | 1 |
| −4 | K023098 | Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit | Mckinley Infuser | 2002 | — |
| −3 | K032642 | Beeline System | Mckinley, Inc. | 2003 | — |
| −2 | K042228 | Beeline Motiv, Propolis, Pca | Mckinley, Inc. | 2004 | — |
| −1 | K050770 | Modification to Accufuser, Accufuser Plus Standard Procedure Kit | Mckinley Medical, LLC | 2005 | — |
| 0 (this device) | K052451 | MPS Acacia Medflo Elastomeric Pump | Mps Acacia | 2005 | — |
| +1 | K081905 | Accuflow and Accuflux Elastomeric Infusion Pump | Westmed, Inc. | 2008 | Class I |
| +2 | K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte., Ltd. | 2016 | — |
| +3 | K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte., Ltd. | 2026 | — |
| +3 | K240624 | InfuLife | First Medical Source, LLC | 2024 | — |
| +3 | K242152 | SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Epic Medical Pte., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 6 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2016 | 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? (4)
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 |
|---|---|---|---|
| * | K011117 | MPS Acacia Medflo Infusion (LI) and MPS Acacia Medflo Infusion (LI) Keep Vein Open (Kvo)…Summary page 1…Elastomeric Infusion Pump 5. Predicate device: Med~loe LI and LI-KVO 510(k) number: K011117 Marketed by: MRPS Acacia 785 Chall… | 2001 |
| * | K003476 | MPS Acacia Pain KitSummary page 1…Brea, CA 92821 Predicate device: MRS Acacia Pain Kit 51 0(k) number: K003476 Marketed by: MPS Acacia 785 Challe… | 2001 |
| * | K020251 | Paragon Infusion SystemSummary page 1…ON-Q, PainBuster, C-Bloc, Eclipse, Easypump, Homepump 51 0(k) number: K020251 Marketed by: I-Flow Corporation 20… | 2002 |
| * | K050770 | Modification to Accufuser, Accufuser Plus Standard Procedure KitSummary page 1…Accufuser, Accufuser Plus, and Standard Procedure Kit 510(k) number: K050770 Marketed by: McKinley Medical, LLC… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081905 | Accuflow and Accuflux Elastomeric Infusion Pump Class I | 2008 | 4 |
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 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- 7 of the 33 ancestors have a recall of any class.
- Of its descendants, K081905 (Westmed, Inc., 2008) has gone furthest, with 4 descendants of its own.
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?
The MPS Acacia MedFlo Elastomeric Pump is indicated for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy, and pain management. Routes of administration include intravenous, intra-arterial, subcutaneous, intramuscular, and epidural. The keep vein open (KVO) version provides a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The MedFlo Elastomeric pump…
Read the full statement (189 words)
The MPS Acacia MedFlo Elastomeric Pump is indicated for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy, and pain management. Routes of administration include intravenous, intra-arterial, subcutaneous, intramuscular, and epidural. The keep vein open (KVO) version provides a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The MedFlo Elastomeric pump may also include an optional Y-site at the distal end of the administration set to allow piggyback infusions, and an optional bolus mechanism intended for patient controlled infusion.
The MPS Acacia MedFlo Elastomeric Pump is also indicated 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 include intraoperative, perineural, and percutaneous.
The MPS Acacia MedFlo Elastomeric Pump is also indicated 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.
The MPS Acacia MedFlo Elastomeric Pump is disposable and single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052451: MPS Acacia Medflo Elastomeric Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052451
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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