# K062005: Portex Epidural Catheter

- Pathway: 510(k) (Special)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Oct 18, 2006 after 93 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
Longest line of descent: 1 generation back to K992471 (1999). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992471: Sims Portex Epidural Catheter, 20G Model# 4910-16/17; 21G Model# 4910-18, Sims Portex, Inc. (1999) Summary page 1.

## Most influential descendants
- K080140: Laurimed Spinal Injection System (2008), 2 descendants of its own
- K083909: Spinal Injection System (2009), 1 descendant of its own
- K091818: Laurimed Spinal Injection System (2009), 0 descendants of its own

## Recalls of this device
- Jul 15, 2009 · Not classified · Z-2050-2009: Portex Continuous Epidural Tray was distributed with a 20G closed end, three eyed, nylon catheter without a stylet instead of the 20 G open end Teflon catheter with stylet specified on the label.

## Indications for use
The Epidural Catheter is indicated for the injection of local anesthetics into the epidural space. The duration of use should not exceed 72 hours.

Source page: https://510kreport.com/device/K062005
Methodology: https://510kreport.com/methodology