510(k) · Cleared
ClearedAccufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mckinley Infuser · MEB Pump, Infusion, Elastomeric
Cleared on Dec 9, 2002 as substantially equivalent to K013928 (Breg, Inc., 2001) and 2 other predicates after an 82-day review. Its family tree reaches back 5 generations to 1990. 1 of the 34 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it.
- Decided
- Dec 9, 2002
- Review
- 82 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K896422 (1990). 16 ancestors in all, the oldest K884505 (1989). 17 later devices descend from it, 3 citing it directly. 1 of the 34 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 deviceK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
- Descendant · cites it directly · 15 of its ownK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
- Descendant · cites it directly · 8 of its ownK032642 Beeline SystemMckinley, Inc. · 2003
- Descendant · 2 generations on · 7 of its ownK042228 Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004
- Descendant · 3 generations on · 6 of its ownK050770 Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005
- Descendant · 4 generations on · 5 of its ownK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K081905 Accuflow and Accuflux Elastomeric Infusion Pump4 generations on · 2008
Most influential descendants
Showing 5 of 17 · See all- K033039Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003 · cites it directly15descendants
- K032642Beeline SystemMckinley, Inc. · 2003 · cites it directly8descendants
- K042228Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004 · 2 generations on7descendants
- K050770Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005 · 3 generations on6descendants
- K052451MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005 · 4 generations on5descendants
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) | K023098 | Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit | Mckinley Infuser | 2002 | — |
| +1 | K033039 | Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits | Mckinley, Inc. | 2003 | — |
| +1 | K032642 | Beeline System | Mckinley, Inc. | 2003 | — |
| +2 | K042228 | Beeline Motiv, Propolis, Pca | Mckinley, Inc. | 2004 | — |
| +3 | K050770 | Modification to Accufuser, Accufuser Plus Standard Procedure Kit | Mckinley Medical, LLC | 2005 | — |
| +4 | K052451 | MPS Acacia Medflo Elastomeric Pump | Mps Acacia | 2005 | — |
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 |
|---|---|---|
| 2003 | 2 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K013928 | Pain Care 3200Summary page 2…rocode: MEB Existing Device Cleared 510(k): K003915, Accufuser and Accufuser Plus Predicate devices demonstrating substantial equivalence include the following. K013928, Breg Corporation, Pain Care 3000 and 3200, and accessory Kit. K014091, Stryker Pain Pump and Accessory Kit. K02086… | 2001 |
| * | K014091 | Stryker PainpumpSummary page 2…Plus Predicate devices demonstrating substantial equivalence include the following. K013928, Breg Corporation, Pain Care 3000 and 3200, and accessory Kit. K014091, Stryker Pain Pump and Accessory Kit. K020862, I-Flow, Infusion Pump and Administration Set. Submitted by: McKinley… | 2001 |
| * | K020862 | I-Flow Elastomeric PumpSummary page 2…ivalence include the following. K013928, Breg Corporation, Pain Care 3000 and 3200, and accessory Kit. K014091, Stryker Pain Pump and Accessory Kit. K020862, I-Flow, Infusion Pump and Administration Set. Submitted by: McKinley Infuser, LLC 63 1 Howard, #202 San Fran… | 2002 |
What descends from it? (17)
See all 173 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 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K033039 (Mckinley, Inc., 2003) has gone furthest, with 15 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 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 Accuhser 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 (134 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 Accuhser 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/K023098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023098: Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023098
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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