# K984502: Nerve Block Infusion Kit

- Pathway: 510(k) (Traditional)
- Applicant: I-Flow Corp.
- Decided: Mar 4, 1999 after 76 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: 3 generations back to K896422 (1990). 6 ancestors in all.
33 later devices descend from it; 4 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)
- K980558: Painbuster Infusion System, I-Flow Corp. (1998) Summary page 1.
- K982946: Painbuster Infusion Kit, I-Flow Corp. (1998) Summary page 1.
- K896422: Burron Ambulatory Drug Delivery System, Burron Medical, Inc. (1990) Summary page 1.
- K944692: C-Series Homepump, Block Medical, Inc. (1995) Summary page 1.
- K982256: Outbound Disposable Syringe Infuser Outbound 2 Disposable Pump, Mckinley, Inc. (1998) Summary page 1.
- (no number) B. Braun Continuous Nerve Block Set: named in the summary without a submission number

## Most influential descendants
- 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
- K042488: Perifix Catheter and Contiplex Catheter (2004), 9 descendants of its own

## Indications for use
The Nerve Block Infusion Kit is intended to provide continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative general and orthopedic surgery. Additional routes of infusion include percutaneous, subcutaneous, epidural and into intraoperative sites.

Source page: https://510kreport.com/device/K984502
Methodology: https://510kreport.com/methodology