KOI — Stimulator, Nerve, Peripheral, Electric Class II
FDA product code KOI covers "Stimulator, Nerve, Peripheral, Electric", a Class II medical device regulated under 21 CFR 868.2775. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KOI
- Device Class
- Class II
- Regulation Number
- 868.2775
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261098 | senzime | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (S | May 22, 2026 |
| K250887 | mipm mammendorfer institut für physik und medizin | Neuromuscular Transmission Monitor TOF3D (2510091) | October 21, 2025 |
| K243339 | idmed | WiTOF | June 23, 2025 |
| K242525 | nerbio medical software platforms | iTOF® | December 5, 2024 |
| K220530 | senzime | Tetragraph Neuromuscular Transmission Monitor | August 17, 2022 |
| K220976 | nihon kohden corporation | Life Scope PT BSM-1700 Series Bedside Monitor | July 21, 2022 |
| K212434 | mipm mammendorfer institut für physik und medizin | Neuromuscular Transmission Monitor TOF3D | May 5, 2022 |
| K213316 | nihon kohden corporation | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM | December 29, 2021 |
| K201949 | nihon kohden corporation | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scop | May 2, 2021 |
| K192958 | blink device | TwitchView System | April 2, 2020 |
| K190795 | senzime | Tetragraph Neuromuscular Transmission Monitor | October 18, 2019 |
| K172690 | idmed | ToFscan | May 31, 2018 |
| K172843 | blink device corporation | TwitchView System | March 29, 2018 |
| K162048 | halyard health - irvine | EZstim*III Peripheral Nerve Stimulator/Nerve Locator | December 5, 2016 |
| K051635 | ge healthcare | DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES | July 15, 2005 |
| K042003 | draeger medical systems | INFINITY TRIDENT NMT POD | September 1, 2004 |
| K023342 | hdc | NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE | March 2, 2004 |
| K002889 | neotonus | PNS MAGNETIC STIMULATOR SYSTEM | April 6, 2001 |
| K992596 | organon teknika | TOF-WATCH S | August 30, 1999 |
| K992598 | organon teknika | TOF-WATCH SX | August 30, 1999 |