Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5150](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5150) → BSP — Needle, Conduction, Anesthetic (W/Wo Introducer)

# BSP · Needle, Conduction, Anesthetic (W/Wo Introducer)

_Anesthesiology · 21 CFR 868.5150 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP

## Overview

- **Product Code:** BSP
- **Device Name:** Needle, Conduction, Anesthetic (W/Wo Introducer)
- **Regulation:** [21 CFR 868.5150](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5150)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **3rd-party reviewable:** yes

## Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 152)

Showing 20 most recent of 152 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243690](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K243690.md) | SonoMSK | PAJUNK GmbH Medizintechnologie | Jul 1, 2025 | SESE |
| [K243682](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K243682.md) | SonoPlex STIM; SonoPlex II | PAJUNK GmbH Medizintechnologie | Jun 27, 2025 | SESE |
| [K250774](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K250774.md) | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture | PAJUNK GmbH Medizintechnologie | Jun 25, 2025 | SESE |
| [K243525](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K243525.md) | SonoTAP and SonoTAP II | PAJUNK GmbH Medizintechnologie | Mar 24, 2025 | SESE |
| [K241953](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K241953.md) | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | PAJUNK GmbH Medizintechnologie | Nov 22, 2024 | SESE |
| [K241954](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K241954.md) | SonoBlock; SonoBlock II | PAJUNK GmbH Medizintechnologie | Sep 11, 2024 | SESE |
| [K240253](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K240253.md) | Reach Needle | Aerin Medical, Inc. | Mar 21, 2024 | SESE |
| [K212982](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K212982.md) | Medispine - Spinal Needle, Glospine - Spinal Needle | Global Medikit Limited | Jul 29, 2022 | SESE |
| [K211085](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K211085.md) | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle | Becton, Dickinson and Company | Jul 1, 2022 | SESE |
| [K210978](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K210978.md) | BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle | Becton, Dickinson and Company | Dec 22, 2021 | SESE |
| [K203668](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K203668.md) | RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles | Myco Medical Supplies, Inc. | Sep 29, 2021 | SESE |
| [K212328](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K212328.md) | DiscCath Needle Set | Disccath, LLC | Sep 26, 2021 | SESE |
| [K193131](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K193131.md) | BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle | Becton, Dickinson and Company | Sep 29, 2020 | SESE |
| [K192914](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K192914.md) | Stimuplex Onvision System | Philips Medical Systems Nederland B.V. | May 27, 2020 | SESE |
| [K191290](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K191290.md) | Ancora Nerve Block Catheter Set | Ancora Medical Technology | Feb 6, 2020 | SESE |
| [K190026](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K190026.md) | Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) | Teleflex Medical | Aug 21, 2019 | SESE |
| [K183316](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K183316.md) | Dr J Spinal and Epidural Needles | Dr. Japan Co., Ltd. | Aug 12, 2019 | SESE |
| [K172823](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K172823.md) | Portex NRFit Epidural Needles | Smiths Medical Asd, Inc. | Jun 12, 2018 | SESE |
| [K173155](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K173155.md) | Pakter Curved Needle Set | Cook Incorporated | Jun 7, 2018 | SESE |
| [K172410](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP/K172410.md) | 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 | Smiths Medical Asd, Inc. | Jun 1, 2018 | SESE |

## Top Applicants

- PAJUNK GmbH Medizintechnologie — 13 clearances
- Pajunk GmbH — 8 clearances
- B.Braun Medical, Inc. — 5 clearances
- Epimed International, Inc. — 5 clearances
- Holgrath Medical Technologies, Inc. — 5 clearances

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSP)

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