# K982256: Outbound Disposable Syringe Infuser Outbound 2 Disposable Pump

- Pathway: 510(k) (Traditional)
- Applicant: Mckinley, Inc.
- Decided: Sep 30, 1998 after 96 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.
39 later devices descend from it; 3 cite it directly.
2 of 40 devices in its family (counting itself) have 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
- K984502: Nerve Block Infusion Kit (1999), 33 descendants of its own
- K020862: I-Flow Elastomeric Pump (2002), 19 descendants of its own
- K023098: Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit (2002), 17 descendants of its own
- K033039: Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits (2003), 15 descendants of its own
- K030830: B. Braun Nerve Block Catheter (2003), 10 descendants of its own

## Indications for use
The OutBound DIP is indicated for intravenous, intra-arterial, subcutaneous, and epidural infusion of medications or fluids requiring continuous delivery at controlled infission rates. The QutBound pump is also intended to provide continuous infusion of a local anaesthetic diroctly into the intracparative site for postoperative pain management.

Source page: https://510kreport.com/device/K982256
Methodology: https://510kreport.com/methodology