# K982946: Painbuster Infusion Kit

- Pathway: 510(k) (Traditional)
- Applicant: I-Flow Corp.
- Decided: Nov 18, 1998 after 89 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: 2 generations back to K896422 (1990). 4 ancestors in all.
42 later devices descend from it; 7 cite it directly.
2 of 47 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 2.
- K896422: Burron Ambulatory Drug Delivery System, Burron Medical, Inc. (1990) Summary page 2.
- K944692: C-Series Homepump, Block Medical, Inc. (1995) Summary page 2.

## 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
- K984146: Paragon Infusion (1999), 11 descendants of its own

## Indications for use
The PainBuster is intended to provide continuous infusion of a local anesthetic directly into an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management. Additional routes of administration include percutaneous and subcutaneous infusion.

Source page: https://510kreport.com/device/K982946
Methodology: https://510kreport.com/methodology