Stimulator, Nerve, Peripheral, Electric
An Electric Peripheral Nerve Stimulator is a device used in anesthesiology to deliver controlled electrical pulses to peripheral nerves, assessing neuromuscular blockade levels during and after general anesthesia to guide the use of muscle relaxants and confirm adequate neuromuscular recovery before extubation. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KOI and it is regulated under 21 CFR 868.2775 in the Anesthesiology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- KOI
- Device Class
- FDA class 2
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 29 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) | May 22, 2026 | Substantially Equivalent | Senzime AB |
| K250887 | Neuromuscular Transmission Monitor TOF3D (2510091) | Oct 21, 2025 | Substantially Equivalent | MIPM Mammendorfer Institut für Physik und Medizin GmbH |
| K243339 | WiTOF | Jun 23, 2025 | Substantially Equivalent | Idmed |
| K242525 | iTOF® | Dec 05, 2024 | Substantially Equivalent | Nerbio Medical Software Platforms, Inc. |
| K220530 | Tetragraph Neuromuscular Transmission Monitor | Aug 17, 2022 | Substantially Equivalent | Senzime AB |
| K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | Jul 21, 2022 | Substantially Equivalent | Nihon Kohden Corporation |
| K212434 | Neuromuscular Transmission Monitor TOF3D | May 05, 2022 | Substantially Equivalent | MIPM Mammendorfer Institut für Physik und Medizin GmbH |
| 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 | Dec 29, 2021 | Substantially Equivalent | Nihon Kohden Corporation |
| K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series | May 02, 2021 | Substantially Equivalent | Nihon Kohden Corporation |
| K192958 | TwitchView System | Apr 02, 2020 | Substantially Equivalent | Blink Device Company |
| K190795 | Tetragraph Neuromuscular Transmission Monitor | Oct 18, 2019 | Substantially Equivalent | Senzime AB |
| K172690 | ToFscan | May 31, 2018 | Substantially Equivalent | Idmed |
| K172843 | TwitchView System | Mar 29, 2018 | Substantially Equivalent | Blink Device Corporation |
| K162048 | EZstim*III Peripheral Nerve Stimulator/Nerve Locator | Dec 05, 2016 | Substantially Equivalent | Halyard Health - Irvine |
| K051635 | DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES | Jul 15, 2005 | Substantially Equivalent | GE Healthcare |
| K042003 | INFINITY TRIDENT NMT POD | Sep 01, 2004 | Substantially Equivalent | Draeger Medical Systems, Inc. |
| K023342 | NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG | Mar 02, 2004 | Substantially Equivalent | Hdc Corp. |
| K002889 | PNS MAGNETIC STIMULATOR SYSTEM | Apr 06, 2001 | Substantially Equivalent | Neotonus, Inc. |
| K992598 | TOF-WATCH SX | Aug 30, 1999 | Substantially Equivalent | Organon Teknika Corp. |
| K992596 | TOF-WATCH S | Aug 30, 1999 | Substantially Equivalent | Organon Teknika Corp. |
| K972698 | TOF-WATCH | Dec 16, 1997 | Substantially Equivalent | Organon Teknika Corp. |
| K955026 | AS/3 NMT MODULE | Apr 28, 1997 | Substantially Equivalent | Datex Medical Instrumentation, Inc. |
| K955031 | MAXISTIM | Dec 10, 1996 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K954505 | EZ STIM | Dec 10, 1996 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K953205 | CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION) | May 23, 1996 | Substantially Equivalent | Fisher & Paykel Healthcare, Ltd. |
| K925159 | TOF-GUARD TRANSMISSION MONITOR | Sep 01, 1993 | Substantially Equivalent | Biometer Intl. A/S |
| K924234 | CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272 | May 27, 1993 | Substantially Equivalent | Fisher & Paykel Electronics , Ltd. |
| K861091 | EASISTIM | Jun 02, 1986 | Substantially Equivalent | Promed Corp. |
| K840108 | NEUROMUSCULAR TRANSMISSION MONITOR | Feb 17, 1984 | Substantially Equivalent | Datex Division Instrumentarium Corp. |
FEI Numbers
This FDA classification entry is associated with 53 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 53 registration numbers. Click on an entry to view related FDA registrations.