# K981329: Feth-R-Kath

- Pathway: 510(k) (Traditional)
- Applicant: Epimed International, Inc.
- Decided: Aug 26, 1998 after 135 days
- Product code: BSO (Catheter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5120
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Arrow International Flex Tip Plus® epidural catheter: named in the summary without a submission number

## Most influential descendants
- K994374: Soaker Catheter (2000), 18 descendants of its own
- 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

## Recalls of this device
- Dec 28, 2017 · Class II · Z-2313-2021: Potential for stylet to protrude from the distal end of the catheter
- Dec 28, 2017 · Class II · Z-2312-2021: Potential for stylet to protrude from the distal end of the catheter

## Indications for use
The Epimed Feth-R-Kath epidural catheter is intended for administration of local anesthetics into the epidural space to provide continuous epidural or caudal anesthesia for up to 72 hours.

Source page: https://510kreport.com/device/K981329
Methodology: https://510kreport.com/methodology