# K172823: Portex NRFit Epidural Needles

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Jun 12, 2018 after 267 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000495 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090261: Portex Tuohy Epidural Needle 17G, Portex Tuohy Epidural Needle 18G, Smiths Medical Asd, Inc. (2009) Summary page 4.

## Indications for use
The PORTEX® Tuohy and Hustead Needles with NRFit™ connectors are intended to facilitate the placement of an epidural catheter and for the injection or infusion of regional anesthetics or narcotics.

Source page: https://510kreport.com/device/K172823
Methodology: https://510kreport.com/methodology