# K173541: Epinaut

- Pathway: 510(k) (Traditional)
- Applicant: Imedicom Co., Ltd.
- Decided: Aug 24, 2018 after 282 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: 1 generation back to K954584 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954584: Racz Epidural Catheter, Medic Evaluation Devices & Instruments Corp. (1996) Summary page 4.

## Indications for use
For administration of anesthetic agents into the epidural space to provide epidural or caudal anesthesia.

Source page: https://510kreport.com/device/K173541
Methodology: https://510kreport.com/methodology