# K051401: ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow Catheter

- Pathway: 510(k) (Traditional)
- Applicant: I-Flow Corp.
- Decided: Nov 30, 2005 after 183 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: 5 generations back to K813186 (1981). 7 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043456: Modification to Soaker Catheter, I-Flow Corp. (2005) Summary page 1.

## Most influential descendants
- K080675: Pajunk Infiltralong Wound Infiltration Catheter Kit (2008), 2 descendants of its own
- K111031: Painfusor Catheter (2011), 1 descendant of its own
- K193664: SubQKath Catheter and Needle Set (2020), 0 descendants of its own
- K072702: Stryker Antimic Catheter (2008), 0 descendants of its own

## Indications for use
1. The ON-Q SilverSoaker Catheter is intended 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. The ON-Q SilverSoaker Catheter is contraindicated for the epidural space and in neonatal populations. 2. The ON-Q SilverSoaker Catheter contains an antimicrobial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.

Source page: https://510kreport.com/device/K051401
Methodology: https://510kreport.com/methodology