510(k) · Cleared
Recalled · Class I · 2014Accuflow and Accuflux Elastomeric Infusion Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Westmed, Inc. · MEB Pump, Infusion, Elastomeric
Cleared on Jul 15, 2008 as substantially equivalent to K050770 (Mckinley Medical, LLC, 2005) and 3 other predicates after a 12-day review. Its family tree reaches back 10 generations to 1990. 1 of the 48 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled 7 times, including a Class I recall.
- Decided
- Jul 15, 2008
- Review
- 12 days
- Class
- Class II
- Product code
- MEB
- Recalls
- 7 (1 Class I)
- Predicates
- 4
Its longest line of descent runs back 10 generations to K896422 (1990). 43 ancestors in all, the oldest K802820 (1980). 4 later devices descend from it, 1 citing it directly. 1 of the 48 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 6 generations between
- 3 generations backK042228 Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004
- 2 generations backK050770 Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005
- 1 generation backK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
- This deviceK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
- 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
- Descendant · 2 generations on · 0 of its ownK242152 SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd. · 2024
Show all 10 generations
- Root · 10 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 9 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 8 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 7 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 6 generations backK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
- 5 generations backK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
- 4 generations backK032642 Beeline SystemMckinley, Inc. · 2003
- 3 generations backK042228 Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004
- 2 generations backK050770 Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005
- 1 generation backK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
- This deviceK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016 · 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
- K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −9 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −8 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −7 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −6 | K020862 | I-Flow Elastomeric Pump | I-Flow Corp. | 2002 | 1 |
| −5 | K023098 | Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit | Mckinley Infuser | 2002 | — |
| −4 | K032642 | Beeline System | Mckinley, Inc. | 2003 | — |
| −3 | K042228 | Beeline Motiv, Propolis, Pca | Mckinley, Inc. | 2004 | — |
| −2 | K050770 | Modification to Accufuser, Accufuser Plus Standard Procedure Kit | Mckinley Medical, LLC | 2005 | — |
| −1 | K052451 | MPS Acacia Medflo Elastomeric Pump | Mps Acacia | 2005 | — |
| 0 (this device) | K081905 | Accuflow and Accuflux Elastomeric Infusion Pump | Westmed, Inc. | 2008 | — |
| +1 | K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte., Ltd. | 2016 | — |
| +2 | K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte., Ltd. | 2026 | — |
| +2 | K240624 | InfuLife | First Medical Source, LLC | 2024 | — |
| +2 | 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 |
|---|---|---|
| 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 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K050770 | Modification to Accufuser, Accufuser Plus Standard Procedure KitSummary page 1…rically Powered Disposable Infusion Pump Classification Name: Elastomeric External Infusion Pump (21 CFR 880.5725) 80 MEB Predicate Device: McKinley Accufuser K050770 cleared April 14, 2005 Baxer Infuser K062457 cleared September 21, 2006… | 2005 |
| * | K062457 | Infusor Small Volume Elastomeric Infusion DevicesSummary page 1…Infusion Pump (21 CFR 880.5725) 80 MEB Predicate Device: McKinley Accufuser K050770 cleared April 14, 2005 Baxer Infuser K062457 cleared September 21, 2006 MPS MedFIo K052451 cleared December 8, 2005… | 2006 |
| * | K052451 | MPS Acacia Medflo Elastomeric PumpSummary page 1…770 cleared April 14, 2005 Baxer Infuser K062457 cleared September 21, 2006 MPS MedFIo K052451 cleared December 8, 2005 I-Flow K052117 cleared September 9, 2005 Device D… | 2005 |
| * | K052117 | I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump)Summary page 1…7 cleared September 21, 2006 MPS MedFIo K052451 cleared December 8, 2005 I-Flow K052117 cleared September 9, 2005 Device Description: The AccuFlo & AccuFlux models are both disposable, non-electric infusion pu… | 2005 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151650 | SMARTez elastomeric infusion pump | 2016 | 3 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2014 | Class II | Z-2655-2014 | Labeling Change Control | The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are a… |
| Dec 13, 2013 | Class II | Z-0921-2014 | Process design | Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications. |
| Oct 20, 2011 | Not classified | Z-0267-2012 | Process control | Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%). |
| Oct 20, 2011 | Not classified | Z-0268-2012 | Process control | Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%). |
| Oct 20, 2011 | Not classified | Z-0269-2012 | Process control | Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%). |
| Jul 28, 2011 | Not classified | Z-0081-2012 | Nonconforming Material/Component | The product may have a higher flow rate than specified resulting in over administration of drug solutions to the patients. |
| Jul 9, 2011 | Class I | Z-0161-2013 | Nonconforming Material/Component | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being reclassified by the Agency as a Class I. The recall was initiated because First Medical Source has… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 10 of the 43 ancestors have a recall of any class.
- Of its descendants, K151650 (Epic Medical Pte., Ltd., 2016) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K050770.
How does its category compare?
All MEB devicesMEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
AccuFlo &AccuFlux devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturer's package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic…
Read the full statement (113 words)
AccuFlo &AccuFlux devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturer's package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes.
The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081905: Accuflow and Accuflux Elastomeric Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081905
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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