# K041585: Autofuser Ambulatory Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Algos, LC
- Decided: Aug 26, 2004 after 73 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 46 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) I-Flow Homepump (Eclipse) C-Series: named in the summary without a submission number
- (no number) Baxter Infuser: named in the summary without a submission number
- (no number) Baxter Intermate: named in the summary without a submission number
- (no number) McKinley Accufuser: named in the summary without a submission number
- (no number) B Braun spring pump: named in the summary without a submission number
- (no number) Sgarlato Pain Control Infusion Pump (PCIP): named in the summary without a submission number

## Most influential descendants
- K060258: Autofuser (2006), 1 descendant of its own
- K090300: Modification to Autofuser (2009), 0 descendants of its own

## Recalls of this device
- May 14, 2009 · Not classified · Z-1846-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1848-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1834-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1840-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1845-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1829-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1862-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1852-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1832-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1868-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1836-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1838-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1859-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1855-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1865-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1847-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1839-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1858-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1863-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1867-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1844-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1856-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1827-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1830-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1837-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1831-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1842-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1826-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1841-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1824-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1861-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1854-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1828-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1851-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1857-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1864-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1835-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1866-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1823-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1849-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1843-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1825-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1860-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1850-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1853-2009: 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 mitiga
- May 14, 2009 · Not classified · Z-1833-2009: 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 mitiga

## Indications for use
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.

Source page: https://510kreport.com/device/K041585
Methodology: https://510kreport.com/methodology