# K111031: Painfusor Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Plan 1 Health, S.R.L.
- Decided: Jul 8, 2011 after 85 days
- Product code: BSO (Catheter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K813186 (1981). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051401: ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow Catheter, I-Flow Corp. (2005) Summary page 1.
- K080675: Pajunk Infiltralong Wound Infiltration Catheter Kit, PAJUNK GmbH Medizintechnologie (2008) Summary page 1.

## Most influential descendants
- K193664: SubQKath Catheter and Needle Set (2020), 0 descendants of its own

## Indications for use
The PAINfusor Catheter, along with related accessory devices, is intended for use to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative, perioperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous.

Source page: https://510kreport.com/device/K111031
Methodology: https://510kreport.com/methodology