Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2775](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2775) → BXN — Stimulator, Nerve, Battery-Powered # BXN · Stimulator, Nerve, Battery-Powered _Anesthesiology · 21 CFR 868.2775 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN ## Overview - **Product Code:** BXN - **Device Name:** Stimulator, Nerve, Battery-Powered - **Regulation:** [21 CFR 868.2775](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2775) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes ## Identification An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 63) Showing 20 most recent of 63 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K213049](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K213049.md) | STIMPOD NMS450 Nerve Stimulator | Xavant Technology (Pty), Ltd. | Oct 16, 2022 | SESE | | [K162086](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K162086.md) | MultiStim ECO | PAJUNK GmbH Medizintechnologie | Jan 6, 2017 | SESE | | [K153045](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K153045.md) | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator | Easy Med Instrument Co., Ltd. | May 13, 2016 | SESE | | [K143095](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K143095.md) | MiniStim MS-IVB Peripheral Nerve Stimulator | Halyard Health, Inc. | Mar 24, 2015 | SESE | | [K140853](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K140853.md) | STIMPOD ST2-3010 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | Nov 6, 2014 | SESE | | [K121743](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K121743.md) | EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN | Sunmed, LLC | Mar 28, 2013 | SESE | | [K111985](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K111985.md) | MYOGUIDE SYSTEM MODEL 8008 | Intronix Technologies Corp. | Dec 30, 2011 | SESE | | [K110118](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K110118.md) | STIMTRODE SINGLE USE NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | Feb 17, 2011 | SESE | | [K102084](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K102084.md) | STIMPOD NMS450 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | Dec 16, 2010 | SESE | | [K093591](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K093591.md) | STIMPOD MODEL NMS-400 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | Dec 3, 2009 | SESE | | [K091155](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K091155.md) | ASCEND | Neurometrix, Inc. | Sep 3, 2009 | SESE | | [K072092](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K072092.md) | XPOD/XMAP NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | Nov 15, 2007 | SESE | | [K070134](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K070134.md) | MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 | Stockert GmbH | Mar 22, 2007 | SESE | | [K062478](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K062478.md) | CLAVIS | Medtronic A/S | Feb 8, 2007 | SESE | | [K061983](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K061983.md) | STIMUPLEX PEN | Stockert GmbH | Nov 21, 2006 | SESE | | [K061172](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K061172.md) | PAJUNK MULTISTIM SENSOR NERVE STIMULATORS | PAJUNK GmbH Medizintechnologie | Oct 17, 2006 | SESE | | [K052313](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K052313.md) | STIMUPLEX HNS-12, MODEL 4892098 | Stockert GmbH | Nov 17, 2005 | SESE | | [K021033](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K021033.md) | STIMUPLEX-DIG-RC NERVE STIMULATOR | B.Braun Medical, Inc. | Mar 21, 2003 | SESE | | [K011308](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K011308.md) | MULTISTIM | Pajunk GmbH | Nov 29, 2001 | SESE | | [K990323](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN/K990323.md) | TE ME NA POLYSTIM NERVE STIMILATOR | Te ME NA S.A.R.L. | Sep 28, 2001 | SESE | ## Top Applicants - Biometer Intl. A/S — 6 clearances - Xavant Technology (Pty), Ltd. — 6 clearances - Stockert GmbH — 4 clearances - Life-Tech Intl., Inc. — 3 clearances - Regional Master Corp. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com