# K990461: Mckinley SP Disposable Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Mckinley, Inc.
- Decided: Jun 30, 1999 after 138 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K032642: Beeline System (2003), 8 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K990461
Methodology: https://510kreport.com/methodology