# K032642: Beeline System

- Pathway: 510(k) (Special)
- Applicant: Mckinley, Inc.
- Decided: Sep 23, 2003 after 27 days
- Product code: FRN (Pump, Infusion)
- 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: 6 generations back to K896422 (1990). 18 ancestors in all.
8 later devices descend from it; 1 cites it directly.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990461: Mckinley SP Disposable Infusion Pump, Mckinley, Inc. (1999) Summary page 1.
- K023098: Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit, Mckinley Infuser (2002) Summary page 2.

## Most influential descendants
- K042228: Beeline Motiv, Propolis, Pca (2004), 7 descendants of its own
- K050770: Modification to Accufuser, Accufuser Plus Standard Procedure Kit (2005), 6 descendants of its own
- 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

## Indications for use
The Beeline system is indicated for intravenous, intra-arterial, enteral, subcutaneous and epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. The Beeline system is also intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative pain management.

Source page: https://510kreport.com/device/K032642
Methodology: https://510kreport.com/methodology