# K241410: EDEN ControlCath

- Pathway: 510(k) (Traditional)
- Applicant: Jmt Co., Ltd.
- Decided: Feb 13, 2025 after 272 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: 3 generations back to K954584 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150789: Spinaut-E, Spinaut-I, Imedicom Co., Ltd. (2016) Summary page 5.

## Indications for use
EDEN ControlCath is used for delivery of drugs that have been indicated for the epidural space.

Source page: https://510kreport.com/device/K241410
Methodology: https://510kreport.com/methodology