FDA product code KOI: Stimulator, Nerve, Peripheral, Electric
KOI is the FDA product code for stimulator, nerve, peripheral, electric. It is a Class II device, regulated under 21 CFR 868.2775 and reviewed by the Anesthesiology panel. FDA has cleared 29 510(k) submissions under KOI, 7 in the last five years, from 20 different applicants. The average 510(k) review took 204 days (median 191); 126 days on average over the last three years. FDA has posted 1 recall for KOI devices.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Nerve, Peripheral, Electric |
| Device class | Class II |
| Regulation | 21 CFR 868.2775 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KOI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 229 |
| 2019 | 1 | 204 |
| 2020 | 1 | 163 |
| 2021 | 2 | 190 |
| 2022 | 3 | 185 |
| 2024 | 1 | 101 |
| 2025 | 2 | 226 |
| 2026 | 1 | 50 |
Compare with all 510(k) review times · Search every KOI clearance
Top KOI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Senzime AB | 3 | 2026-05-22 |
| Nihon Kohden Corporation | 3 | 2022-07-21 |
| Organon Teknika Corp. | 3 | 1999-08-30 |
| MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2 | 2025-10-21 |
| Idmed | 2 | 2025-06-23 |
15 more applicants have KOI clearances. See the full list in Caduvo.
Most recent KOI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261098 | Senzime AB | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) | 2026-05-22 | 50 |
| K250887 | MIPM Mammendorfer Institut für Physik und Medizin GmbH | Neuromuscular Transmission Monitor TOF3D (2510091) | 2025-10-21 | 210 |
| K243339 | Idmed | WiTOF | 2025-06-23 | 241 |
| K242525 | Nerbio Medical Software Platforms, Inc. | iTOF® | 2024-12-05 | 101 |
| K220530 | Senzime AB | Tetragraph Neuromuscular Transmission Monitor | 2022-08-17 | 174 |
Recalls for KOI devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-04-09.
Frequently asked questions
What is FDA product code KOI?
KOI is the FDA product code for stimulator, nerve, peripheral, electric. It is a Class II device, regulated under 21 CFR 868.2775 and reviewed by the Anesthesiology panel.
What device class is KOI?
Class II, regulation 21 CFR 868.2775. Typical premarket route: 510(k).
How long does a 510(k) take for product code KOI?
Across 29 cleared submissions the average was 204 days from receipt to decision (median 191).
Which companies have the most KOI clearances?
Senzime AB (3); Nihon Kohden Corporation (3); Organon Teknika Corp. (3); MIPM Mammendorfer Institut für Physik und Medizin GmbH (2); Idmed (2).
Have KOI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-04-09.
Next steps
- Run an FDA pathway report with predicate devices for product code KOI
- Run a recall and safety report across every KOI manufacturer
- Watch product code KOI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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