# K954584: Racz Epidural Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medic Evaluation Devices & Instruments Corp.
- Decided: Oct 8, 1996 after 372 days
- Product code: BSO (Catheter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5120
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K023140: Versa-Kath Epidural Catheter, Model 156-2124 (2003), 5 descendants of its own
- K980734: Myelotec Video Guided Catheter (1998), 4 descendants of its own
- 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
- K150789: Spinaut-E, Spinaut-I (2016), 1 descendant of its own

## Recalls of this device
- Feb 1, 2021 · Class II · Z-1276-2021: Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off

Source page: https://510kreport.com/device/K954584
Methodology: https://510kreport.com/methodology