510(k) · Cleared
Recalled · 2009Autofuser Ambulatory Infusion Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Algos, LC · MEB Pump, Infusion, Elastomeric
Cleared on Aug 26, 2004 after a 73-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled 46 times.
- Decided
- Aug 26, 2004
- Review
- 73 days
- Class
- Class II
- Product code
- MEB
- Recalls
- 46
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041585 | Autofuser Ambulatory Infusion Pump | Algos, LC | 2004 | — |
| +1 | K060258 | Autofuser | Ace Medical Us, LLC | 2006 | 46 |
| +2 | K090300 | Modification to Autofuser | Ace Medical Us, LLC | 2009 | 16 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 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.
Planning a device in MEB? 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? (6)
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 |
|---|---|---|---|
| * | — | I-Flow Homepump (Eclipse) C-Series Named without a submission number | |
| * | — | Baxter Infuser Named without a submission number | |
| * | — | Baxter Intermate Named without a submission number | |
| * | — | McKinley Accufuser Named without a submission number | |
| * | — | B Braun spring pump Named without a submission number | |
| * | — | Sgarlato Pain Control Infusion Pump (PCIP) Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060258 | Autofuser | 2006 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 14, 2009 | Not classified | Z-1846-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1848-2009 | Process control | TFailure to infuse and potential compromised sterility: he seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1834-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1840-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1845-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1829-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1862-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1852-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1832-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1868-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1836-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1838-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1859-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1855-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1865-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1847-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1839-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1858-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1863-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1867-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1844-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1856-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1827-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1830-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1837-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1831-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1842-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1826-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1841-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1824-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1861-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1854-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1828-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1851-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1857-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1864-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1835-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1866-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1823-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1849-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1843-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1825-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1860-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1850-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1853-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
| May 14, 2009 | Not classified | Z-1833-2009 | Process control | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
The 5 latest of 46 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060258 (Ace Medical Us, LLC, 2006) has gone furthest, with 1 descendant 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
2007high 5 (2007) · low 0 (2010)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MEB
42in 2007
2007high 42 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEB
17in 2018
2007high 48 (2009) · low 0 (2012)2026
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MEB
1,408in 2025
2007high 2,980 (2015) · low 110 (2007)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 AutoFuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, is intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites.
Within the AutoFuser family are pump models intended for patient-controlled infusion using the integrated bolus button.
General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041585 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041585: Autofuser Ambulatory Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041585
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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