# K172410: Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Jun 1, 2018 after 296 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K965017 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110053: Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit, Smiths Medical Asd, Inc. (2012) Summary page 4.

## Recalls of this device
- Dec 8, 2020 · Class II · Z-0152-2022: The labeling was missing information on sterilization and prohibition of reuse.
- Feb 28, 2020 · Class II · Z-1820-2020: Cases of Portex¿ Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. The product was correct, but the inner trays were labeled as 4824PL-20 instead of 4826PL-20.

## Indications for use
PORTEX® products and components with the NRFit™ Connector are intended for the injection or infusion of regional anesthetics or narcotics. The PORTEX® LOR Syringe with NRFit™ Connector is intended for use with the NRFit™ compatible components to verify needle tip placement in the epidural space by the Loss of Resistance technique using air or saline. The NRFit™ Connector is designed to be used with regional anesthesia systems only. The PORTEX® EpiFuse Catheter with NRFit™ Connector is intended for use with the catheter and compatible components for the injection or infusion of regional anesthetics or narcotics. The key is a tool for re-opening the catheter connector. The PORTEX® Epidural Flat Filter with NRFit™ Connector is designed for use when administering injections and/or infusions of regional anesthetics or narcotics to a patient via compatible system components. The NRFit™ Connector is designed to be used with regional anesthesia systems only. The PORTEX® Filter Needle with NRFit™ Connector and PORTEX® Filter Straw with NRFit™ Connector are intended to draw up medication when using the PORTEX® LOR Syringe.

Source page: https://510kreport.com/device/K172410
Methodology: https://510kreport.com/methodology