# K043456: Modification to Soaker Catheter

- Pathway: 510(k) (Special)
- Applicant: I-Flow Corp.
- Decided: Jan 11, 2005 after 27 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: 4 generations back to K813186 (1981). 6 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991543: Intraop Catheter, I-Flow Corp. (1999) Summary page 1.
- K994374: Soaker Catheter, I-Flow Corp. (2000) Summary page 1.
- K022869: Soaker Catheter, I-Flow Corp. (2002) Summary page 1.

## Most influential descendants
- K143164: ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set (2014), 4 descendants of its own
- K051401: ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow Catheter (2005), 4 descendants of its own
- K080675: Pajunk Infiltralong Wound Infiltration Catheter Kit (2008), 2 descendants of its own
- K152952: E-Cath (2016), 1 descendant of its own
- K111031: Painfusor Catheter (2011), 1 descendant of its own

## Indications for use
1. With I-Flow Corporation's ON-Q, PainBuster and C-bloc pain management kits; and 2. As a stand alone device to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves. Routes of administration may be intraoperative, percutaneous, epidural or perineural. The Soaker version of the I-Flow Catheter is contraindicated for the epidural space.

Source page: https://510kreport.com/device/K043456
Methodology: https://510kreport.com/methodology