KOI · Class II · 21 CFR 868.2775

FDA Product Code KOI: Stimulator, Nerve, Peripheral, Electric

Leading manufacturers include Senzime AB, Nihon Kohden Corporation and Idmed.

29
Total
29
Cleared
204d
Avg days
1984
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 151d recently vs 213d historically

FDA 510(k) Cleared Stimulator, Nerve, Peripheral, Electric Devices (Product Code KOI)

29 devices
1–24 of 29
Cleared May 22, 2026
TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)
K261098
Senzime AB
Anesthesiology · 50d
Cleared Oct 21, 2025
Neuromuscular Transmission Monitor TOF3D (2510091)
K250887
MIPM Mammendorfer Institut f?r Physik und Medizin GmbH
Anesthesiology · 210d
Cleared Jun 23, 2025
WiTOF
K243339
Idmed
Anesthesiology · 241d
Cleared Dec 05, 2024
iTOF®
K242525
Nerbio Medical Software Platforms, Inc.
Anesthesiology · 101d
Cleared Aug 17, 2022
Tetragraph Neuromuscular Transmission Monitor
K220530
Senzime AB
Anesthesiology · 174d
Cleared Jul 21, 2022
Life Scope PT BSM-1700 Series Bedside Monitor
K220976
Nihon Kohden Corporation
Anesthesiology · 108d
Cleared May 05, 2022
Neuromuscular Transmission Monitor TOF3D
K212434
MIPM Mammendorfer Institut f?r Physik und Medizin GmbH
Anesthesiology · 274d
Cleared Dec 29, 2021
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
K213316
Nihon Kohden Corporation
Anesthesiology · 86d
Cleared May 02, 2021
Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
K201949
Nihon Kohden Corporation
Anesthesiology · 293d
Cleared Apr 02, 2020
TwitchView System
K192958
Blink Device Company
Anesthesiology · 163d
Cleared Oct 18, 2019
Tetragraph Neuromuscular Transmission Monitor
K190795
Senzime AB
Anesthesiology · 204d
Cleared May 31, 2018
ToFscan
K172690
Idmed
Anesthesiology · 267d
Cleared Mar 29, 2018
TwitchView System
K172843
Blink Device Corporation
Anesthesiology · 191d
Cleared Jul 15, 2005
DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES
K051635
Ge Healthcare
Anesthesiology · 25d

About Product Code KOI - Regulatory Context

510(k) Submission Activity

29 total 510(k) submissions under product code KOI since 1984, with 29 receiving FDA clearance (average review time: 204 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - KOI Product Code

Recent submissions under KOI have taken an average of 151 days to reach a decision - down from 213 days historically, suggesting improved FDA processing for this classification.

KOI devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →