KOI
- Product code
- KOI
- Device name
- Stimulator, Nerve, Peripheral, Electric
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.2775
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 29 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261098 | 2026-05-22 | Senzime AB | TetraGraph Neuromuscular Transmission Monitor (SEN 2… | FDA |
| K250887 | 2025-10-21 | MIPM Mammendorfer Institut für Physik … | Neuromuscular Transmission Monitor TOF3D (2510091) | |
| K243339 | 2025-06-23 | Idmed | WiTOF | FDA |
| K242525 | 2024-12-05 | Nerbio Medical Software Platforms, Inc… | iTOF® |
Official FDA classification page: KOI
Classification and pathway per current FDA publications. Data from openFDA (CC0).