# K994275: Sims Portex Anesthesia Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Sims Portex, Inc.
- Decided: Feb 22, 2000 after 64 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K813186 (1981). 2 ancestors in all.
1 later device descends 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)
- K992471: Sims Portex Epidural Catheter, 20G Model# 4910-16/17; 21G Model# 4910-18, Sims Portex, Inc. (1999) Summary page 2.
- K813186: Perfix Set for Epidural Anesthesia W/Tuo, Burron Medical Products, Inc. (1981) Summary page 2.

## Most influential descendants
- K121525: Perifuse Catheter (2012), 0 descendants of its own

## Indications for use
The SIMS Portex Anesthesia Catheter is indicated for the infusion of local anesthetics or narcotics into the intrapperative site for post operative pain management and for regional anesthesia, outside of the epidural space. Routes of administration may include intraoperative or percutaneous. The catheter is not intended for intravenous or mtramuscular use.

Source page: https://510kreport.com/device/K994275
Methodology: https://510kreport.com/methodology