# K060119: Mckinley Saturation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mckinley Medical, LLC
- Decided: Apr 12, 2006 after 85 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: 3 generations back to K813186 (1981). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031600: Conduction Catheter, Micor, Inc. (2003) Summary page 1.
- K003966: Wundcath Conduction Catheter, Micor, Inc. (2001) Summary page 1.
- K994374: Soaker Catheter, I-Flow Corp. (2000) Summary page 1.

## Indications for use
The McKinley Saturation Catheter is intended for continuous and/or intermittent infusion of pain medication to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, subcutaneous or percutaneous.

Source page: https://510kreport.com/device/K060119
Methodology: https://510kreport.com/methodology