# K050770: Modification to Accufuser, Accufuser Plus Standard Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: Mckinley Medical, LLC
- Decided: Apr 14, 2005 after 20 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K896422 (1990). 24 ancestors in all.
6 later devices descend from it; 2 cite it directly.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042228: Beeline Motiv, Propolis, Pca, Mckinley, Inc. (2004) Summary page 2.
- K040337: I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump), I-Flow Corp. (2004) Summary page 2.

## Most influential descendants
- K052451: MPS Acacia Medflo Elastomeric Pump (2005), 5 descendants of its own
- K081905: Accuflow and Accuflux Elastomeric Infusion Pump (2008), 4 descendants of its own
- K151650: SMARTez elastomeric infusion pump (2016), 3 descendants of its own
- K250234: SMARTeZ™ Elastomeric Infusion Pump (RS series) (2026), 0 descendants of its own
- K240624: InfuLife (2024), 0 descendants of its own

## Indications for use
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 Accufuser 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. The Accufuser and Accufuser Plus systems are intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

Source page: https://510kreport.com/device/K050770
Methodology: https://510kreport.com/methodology