# K060258: Autofuser

- Pathway: 510(k) (Traditional)
- Applicant: Ace Medical Us, LLC
- Decided: May 30, 2006 after 118 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
Longest line of descent: 7 generations back to K896422 (1990). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041585: Autofuser Ambulatory Infusion Pump, Algos, LC (2004) Summary page 1.
- K033039: Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits, Mckinley, Inc. (2003) Summary page 2.
- K980558: Painbuster Infusion System, I-Flow Corp. (1998) Summary page 2.
- K982946: Painbuster Infusion Kit, I-Flow Corp. (1998) Summary page 2.
- K944692: C-Series Homepump, Block Medical, Inc. (1995) Summary page 2.
- K896546: Homepump (Disp. Elastomeric Infusion Device), Block Medical, Inc. (1990) Summary page 2.

## Most influential descendants
- 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 administration include intravenous, percutaneous, subcutaneous, intra-arterial and epidurar, 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/K060258
Methodology: https://510kreport.com/methodology