# K935927: Concord/Portex Epidural Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Industries Medical Systems, Inc.
- Decided: Sep 9, 1994 after 270 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K033080: Portex 24G Pediatric Epidural and Peripheral Block Anesthesia Catheter (2004), 2 descendants of its own
- K062902: Pajunks Epilong Set Pediatric (2007), 1 descendant of its own
- K090884: Perifix One Pediatric Catheter, 20 GA. & 24 GA. (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K935927
Methodology: https://510kreport.com/methodology