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) → KOI — Stimulator, Nerve, Peripheral, Electric # KOI · Stimulator, Nerve, Peripheral, Electric _Anesthesiology · 21 CFR 868.2775 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI ## Overview - **Product Code:** KOI - **Device Name:** Stimulator, Nerve, Peripheral, Electric - **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 28) Showing 20 most recent of 28 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250887](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K250887.md) | Neuromuscular Transmission Monitor TOF3D (2510091) | MIPM Mammendorfer Institut für Physik und Medizin GmbH | Oct 21, 2025 | SESE | | [K243339](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K243339.md) | WiTOF | Idmed | Jun 23, 2025 | SESE | | [K242525](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K242525.md) | iTOF® | Nerbio Medical Software Platforms, Inc. | Dec 5, 2024 | SESE | | [K220530](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K220530.md) | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | Aug 17, 2022 | SESE | | [K220976](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K220976.md) | Life Scope PT BSM-1700 Series Bedside Monitor | Nihon Kohden Corporation | Jul 21, 2022 | SESE | | [K212434](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K212434.md) | Neuromuscular Transmission Monitor TOF3D | MIPM Mammendorfer Institut für Physik und Medizin GmbH | May 5, 2022 | SESE | | [K213316](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K213316.md) | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM | Nihon Kohden Corporation | Dec 29, 2021 | SESE | | [K201949](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K201949.md) | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series | Nihon Kohden Corporation | May 2, 2021 | SESE | | [K192958](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K192958.md) | TwitchView System | Blink Device Company | Apr 2, 2020 | SESE | | [K190795](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K190795.md) | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | Oct 18, 2019 | SESE | | [K172690](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K172690.md) | ToFscan | Idmed | May 31, 2018 | SESE | | [K172843](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K172843.md) | TwitchView System | Blink Device Corporation | Mar 29, 2018 | SESE | | [K162048](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K162048.md) | EZstim*III Peripheral Nerve Stimulator/Nerve Locator | Halyard Health - Irvine | Dec 5, 2016 | SESE | | [K051635](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K051635.md) | DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES | GE Healthcare | Jul 15, 2005 | SESE | | [K042003](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K042003.md) | INFINITY TRIDENT NMT POD | Draeger Medical Systems, Inc. | Sep 1, 2004 | SESE | | [K023342](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K023342.md) | NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG | Hdc Corp. | Mar 2, 2004 | SESE | | [K002889](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K002889.md) | PNS MAGNETIC STIMULATOR SYSTEM | Neotonus, Inc. | Apr 6, 2001 | SESE | | [K992598](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K992598.md) | TOF-WATCH SX | Organon Teknika Corp. | Aug 30, 1999 | SESE | | [K992596](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K992596.md) | TOF-WATCH S | Organon Teknika Corp. | Aug 30, 1999 | SESE | | [K972698](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K972698.md) | TOF-WATCH | Organon Teknika Corp. | Dec 16, 1997 | SESE | ## Top Applicants - Nihon Kohden Corporation — 3 clearances - Organon Teknika Corp. — 3 clearances - Idmed — 2 clearances - Life-Tech Intl., Inc. — 2 clearances - MIPM Mammendorfer Institut für Physik und Medizin GmbH — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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