# K980558: Painbuster Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: I-Flow Corp.
- Decided: May 28, 1998 after 104 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: 1 generation back to K896422 (1990). 3 ancestors in all.
47 later devices descend from it; 7 cite it directly.
2 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896422: Burron Ambulatory Drug Delivery System, Burron Medical, Inc. (1990) Summary page 2.
- K944692: C-Series Homepump, Block Medical, Inc. (1995) Summary page 2.
- K932740: Homepump NSF, Block Medical, Inc. (1993) Summary page 2.

## Most influential descendants
- K982946: Painbuster Infusion Kit (1998), 42 descendants of its own
- 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

## Indications for use
The PainBuster is intended to provide continuous infusion of a local anesthetic directly into the intraoperative (soft tissue / body cavity) site for postoperative pain management. The PainBuster is intended to deliver pain medication percutaneously via an administration set attached to a catheter. The PainBuster is single use only. The PainBuster is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment. The PainBuster is not intended for epidural, subcutaneous or vascular drug delivery. The PainBuster is not intended for chemotherapy drugs. No testing has been conducted to determine the efficacy of the PainBuster for the delivery of blood, blood products or TPN. The PainBuster is not intended for the delivery of blood, blood products or TPN.

Source page: https://510kreport.com/device/K980558
Methodology: https://510kreport.com/methodology