KOI · Stimulator, Nerve, Peripheral, Electric
Anesthesiology · 21 CFR 868.2775 · Class 2
Overview
| Product Code | KOI |
|---|---|
| Device Name | Stimulator, Nerve, Peripheral, Electric |
| Regulation | 21 CFR 868.2775 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 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 | Neuromuscular Transmission Monitor TOF3D (2510091) | MIPM Mammendorfer Institut für Physik und Medizin GmbH | Oct 21, 2025 | SESE |
| K243339 | WiTOF | Idmed | Jun 23, 2025 | SESE |
| K242525 | iTOF® | Nerbio Medical Software Platforms, Inc. | Dec 5, 2024 | SESE |
| K220530 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | Aug 17, 2022 | SESE |
| K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | Nihon Kohden Corporation | Jul 21, 2022 | SESE |
| K212434 | Neuromuscular Transmission Monitor TOF3D | MIPM Mammendorfer Institut für Physik und Medizin GmbH | May 5, 2022 | SESE |
| K213316 | 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 | 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 | TwitchView System | Blink Device Company | Apr 2, 2020 | SESE |
| K190795 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | Oct 18, 2019 | SESE |
| K172690 | ToFscan | Idmed | May 31, 2018 | SESE |
| K172843 | TwitchView System | Blink Device Corporation | Mar 29, 2018 | SESE |
| K162048 | EZstim*III Peripheral Nerve Stimulator/Nerve Locator | Halyard Health - Irvine | Dec 5, 2016 | SESE |
| K051635 | DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES | GE Healthcare | Jul 15, 2005 | SESE |
| K042003 | INFINITY TRIDENT NMT POD | Draeger Medical Systems, Inc. | Sep 1, 2004 | SESE |
| K023342 | 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 | PNS MAGNETIC STIMULATOR SYSTEM | Neotonus, Inc. | Apr 6, 2001 | SESE |
| K992598 | TOF-WATCH SX | Organon Teknika Corp. | Aug 30, 1999 | SESE |
| K992596 | TOF-WATCH S | Organon Teknika Corp. | Aug 30, 1999 | SESE |
| K972698 | 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
