Portex NRFit Epidural Needles
FDA 510(k) K172823 · Smiths Medical Asd, Inc.
510(k) numberK172823
Submission
- Device name
- Portex NRFit Epidural Needles
- Applicant
- Smiths Medical Asd, Inc.
Plymouth, MN, US - Received
- September 18, 2017
- Decision date
- June 12, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSP – Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5150
- Specialty
- Anesthesiology
Other 510(k)s with product code BSP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243690 | SonoMSKBSP · Traditional | PAJUNK GmbH Medizintechnologie | 07/01/2025SE |
| K243682 | SonoPlex STIM; SonoPlex IIBSP · Traditional | PAJUNK GmbH Medizintechnologie | 06/27/2025SE |
| K250774 | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureBSP · Traditional | PAJUNK GmbH Medizintechnologie | 06/25/2025SE |
| K243525 | SonoTAP and SonoTAP IIBSP · Traditional | PAJUNK GmbH Medizintechnologie | 03/24/2025SE |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyBSP · Traditional | PAJUNK GmbH Medizintechnologie | 11/22/2024SE |
| K241954 | SonoBlock; SonoBlock IIBSP · Traditional | PAJUNK GmbH Medizintechnologie | 09/11/2024SE |
| K240253 | Reach NeedleBSP · Traditional | Aerin Medical, Inc. | 03/21/2024SE |
| K212982 | Medispine - Spinal Needle, Glospine - Spinal NeedleBSP · Traditional | Global Medikit Limited | 07/29/2022SE |
| K211085 | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBSP · Traditional | Becton, Dickinson and Company | 07/01/2022SE |
| K210978 | BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer NeedleBSP · Traditional | Becton, Dickinson and Company | 12/22/2021SE |
More from Becton, Dickinson and Company
| 510(k) | Device | Decision |
|---|---|---|
| K232943 | Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space SyringeQNQ · Traditional | 05/31/2024SE |
| K210833 | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy…JOH · Traditional | 11/26/2021SE |
| K211634 | Hypodermic Needle-Pro EDGE Safety DeviceFMI · Special | 08/26/2021SE |
| K192375 | Intellifuse Administration and Intellifuse Blood Administration SetsFPA · Traditional | 09/18/2020SE |
| K181699 | Level 1 Convective WarmerDWJ · Traditional | 07/26/2018SE |
| K172800 | Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal…MIA · Traditional | 06/14/2018SE |
| K172410 | Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of…BSP · Traditional | 06/01/2018SE |
| K172592 | CADD Yellow High Volume Administration Set with NRFit connectorPWH · Traditional | 05/17/2018SE |
| K173912 | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…JOH · Traditional | 05/08/2018SE |
| K171968 | EchoGlo NeedleBSP · Traditional | 01/25/2018SE |
Questions and answers
When was Portex NRFit Epidural Needles cleared by the FDA?
Portex NRFit Epidural Needles (K172823) received a 510(k) decision of Substantially Equivalent on June 12, 2018, 267 days after the submission was received.
What is the product code of K172823?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.