# K090300: Modification to Autofuser

- Pathway: 510(k) (Special)
- Applicant: Ace Medical Us, LLC
- Decided: Apr 30, 2009 after 83 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K896422 (1990). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060258: Autofuser, Ace Medical Us, LLC (2006) Summary page 1.

## Recalls of this device
- Oct 2, 2018 · Class II · Z-0943-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca
- Oct 2, 2018 · Class II · Z-0949-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca
- Oct 2, 2018 · Class II · Z-0950-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca
- Oct 2, 2018 · Class II · Z-0955-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca
- Oct 2, 2018 · Class II · Z-0956-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca
- Oct 2, 2018 · Class II · Z-0940-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca
- Oct 2, 2018 · Class II · Z-0941-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca
- Oct 2, 2018 · Class II · Z-0942-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca
- Oct 2, 2018 · Class II · Z-0946-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca
- Oct 2, 2018 · Class II · Z-0954-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca
- Oct 2, 2018 · Class II · Z-0945-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca
- Oct 2, 2018 · Class II · Z-0948-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca
- Oct 2, 2018 · Class II · Z-0953-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca
- Oct 2, 2018 · Class II · Z-0947-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca
- Oct 2, 2018 · Class II · Z-0951-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca
- Oct 2, 2018 · Class II · Z-0952-2019: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is loca

## 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 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/K090300
Methodology: https://510kreport.com/methodology