# K023140: Versa-Kath Epidural Catheter, Model 156-2124

- Pathway: 510(k) (Traditional)
- Applicant: Epimed International, Inc.
- Decided: Aug 15, 2003 after 329 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
Longest line of descent: 1 generation back to K954584 (1996). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 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 1.

## Most influential descendants
- K043500: Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad Introducer Needle (2005), 3 descendants of its own
- K061210: Functional  Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer Needle, Model D01B (2006), 2 descendants of its own
- K063071: Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B (2007), 1 descendant of its own
- K073516: Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, Regular (2008), 0 descendants of its own
- K050557: Amt Nanocath (2005), 0 descendants of its own

## Recalls of this device
- Jun 18, 2019 · Class II · Z-2069-2019: Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
- Jun 18, 2019 · Class II · Z-2068-2019: Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.

## Indications for use
For administration of anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia for up to 72 hours.

Source page: https://510kreport.com/device/K023140
Methodology: https://510kreport.com/methodology