510(k) · Cleared
ClearedModification to: Accufuser, Accufuser Plus, Standard Procedure Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mckinley, Inc. · MEB Pump, Infusion, Elastomeric
Cleared on Oct 7, 2003 as substantially equivalent to K023098 (Mckinley Infuser, 2002) after an 8-day review. Its family tree reaches back 6 generations to 1990. 1 of the 33 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.
- Decided
- Oct 7, 2003
- Review
- 8 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K896422 (1990). 17 ancestors in all, the oldest K884505 (1989). 15 later devices descend from it, 5 citing it directly. 1 of the 33 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 5 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 4 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 3 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 2 generations backK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
- 1 generation backK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
- This deviceK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
- Descendant · cites it directly · 7 of its ownK042228 Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004
- Descendant · 2 generations on · 6 of its ownK050770 Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005
- Descendant · 3 generations on · 5 of its ownK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
- Descendant · 3 generations on · 4 of its ownK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Recalled (Class I)
- Descendant · 4 generations on · 3 of its ownK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K081905 Accuflow and Accuflux Elastomeric Infusion Pump3 generations on · 2008
Most influential descendants
Showing 5 of 15 · See all- K042228Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004 · cites it directly7descendants
- K050770Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005 · 2 generations on6descendants
- K052451MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005 · 3 generations on5descendants
- K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 3 generations on4descendants
- K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −5 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −4 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −3 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −2 | K020862 | I-Flow Elastomeric Pump | I-Flow Corp. | 2002 | 1 |
| −1 | K023098 | Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit | Mckinley Infuser | 2002 | — |
| 0 (this device) | K033039 | Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits | Mckinley, Inc. | 2003 | — |
| +1 | K042228 | Beeline Motiv, Propolis, Pca | Mckinley, Inc. | 2004 | — |
| +2 | K050770 | Modification to Accufuser, Accufuser Plus Standard Procedure Kit | Mckinley Medical, LLC | 2005 | — |
| +3 | K052451 | MPS Acacia Medflo Elastomeric Pump | Mps Acacia | 2005 | — |
| +3 | K081905 | Accuflow and Accuflux Elastomeric Infusion Pump | Westmed, Inc. | 2008 | Class I |
| +4 | K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte., Ltd. | 2016 | — |
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 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 1 |
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K023098 | Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion KitSummary page 1…s submission is intended to notify the Food and Drug Administration that McKinley, Inc. intends to market a modification to an existing device (K023098) called the Accufuser/Accufuser Plus system. The modification to the existing device is the addition of procedure ki… | 2002 |
What descends from it? (15)
See all 155 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)
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 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 4 of the 17 ancestors have a recall of any class.
- Of its descendants, K042228 (Mckinley, Inc., 2004) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K023098.
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 Accufuser and Accufuser Plus systems are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into the intra-operative (soft tissue/body cavity) site. The Accufuser Plus is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include pain management for preoperative, perioperative, and postoperative surgery. The…
Read the full statement (132 words)
The Accufuser and Accufuser Plus systems are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into the intra-operative (soft tissue/body cavity) site. The Accufuser Plus is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include pain management for preoperative, perioperative, and postoperative surgery.
The Accufuser and Accufuser Plus systems are 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.
The Accufuser/Accufuser Plus system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033039: Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033039
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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