Portex NRFit Epidural Needles

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K172823 ↗

FDA Product Code

BSP

Device Class

Class II

Regulation

21 CFR Part 868.5150

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Smiths Medical Asd, Inc. →

• Are the Portex NRFit Epidural Needles designed for reuse in clinical settings, or are they intended for single-use only?

  The Portex NRFit Epidural Needles are explicitly labeled as single-use devices. This design ensures patient safety and sterility, as they are intended for one-time use in epidural anesthesia procedures before disposal.

• What types of connectors are compatible with the Portex NRFit Epidural Needles, and how does this affect their use?

  These needles are designed to be compatible with the NRFit connector system, which provides a secure and standardized connection for administering local anesthetics or therapeutic agents into the epidural space. This compatibility ensures proper functionality and reduces the risk of disconnections during use.

• How are the Portex NRFit Epidural Needles supplied, and what should clinicians expect in terms of sterility?

  The needles are supplied as sterile, single-use devices, ready for immediate clinical use in settings like operating rooms or procedural suites. The sterility ensures they meet regulatory standards for conduction anesthesia needles, minimizing infection risks.

• What regulatory pathway was followed for the FDA clearance of the Portex NRFit Epidural Needles, and what does this mean for clinicians?

  The Portex NRFit Epidural Needles received FDA clearance through a 510(k) submission, classified under Traditional clearance with a Substantially Equivalent determination. This means the device was reviewed by the FDA’s Anesthesiology (AN) Advisory Committee and deemed comparable to legally marketed predecessors, ensuring compliance with safety and performance standards for conduction anesthesia needles.