# K994374: Soaker Catheter

- Pathway: 510(k) (Traditional)
- Applicant: I-Flow Corp.
- Decided: Mar 3, 2000 after 67 days
- Product code: FRN (Pump, Infusion)
- 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 K813186 (1981). 4 ancestors in all.
18 later devices descend from it; 6 cite it directly.
0 of 23 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.
- K840202: Epidural Catheter, Aries Medical, Inc. (1984) Summary page 1.
- K813186: Perfix Set for Epidural Anesthesia W/Tuo, Burron Medical Products, Inc. (1981) Summary page 1.
- K981329: Feth-R-Kath, Epimed International, Inc. (1998) Summary page 1.

## Most influential descendants
- K022869: Soaker Catheter (2002), 12 descendants of its own
- K043456: Modification to Soaker Catheter (2005), 11 descendants of its own
- 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

## Indications for use
The Soaker Catheter is intended to be used as follows: 1. With I-Flow Corporation’s PainBuster, ON-Q and Nerve Block pain management kits; and 2. As a stand alone device to provide continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative or percutaneous.

Source page: https://510kreport.com/device/K994374
Methodology: https://510kreport.com/methodology