Atlas FDA

KOI

29 FDA 510(k) clearances · Product code

191 daysmedian time to decision
439 days90th percentile
29clearances measured

FDA profile

Official device name
Stimulator, Nerve, Peripheral, Electric
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2775
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 1 · 1998: 1 · 2003: 2 · 2014: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) (K261098)Senzime AB2026-05-22
Neuromuscular Transmission Monitor TOF3D (2510091) (K250887)MIPM Mammendorfer Institut für Physik und Medizin GmbH2025-10-21
WiTOF (K243339)Idmed2025-06-23
iTOF® (K242525)Nerbio Medical Software Platforms, Inc.2024-12-05
Tetragraph Neuromuscular Transmission Monitor (K220530)Senzime AB2022-08-17
Life Scope PT BSM-1700 Series Bedside Monitor (K220976)Nihon Kohden Corporation2022-07-21
Neuromuscular Transmission Monitor TOF3D (K212434)MIPM Mammendorfer Institut für Physik und Medizin GmbH2022-05-05
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 Corporation2021-12-29
Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series (K201949)Nihon Kohden Corporation2021-05-02
TwitchView System (K192958)Blink Device Company2020-04-02
Tetragraph Neuromuscular Transmission Monitor (K190795)Senzime AB2019-10-18
ToFscan (K172690)Idmed2018-05-31
TwitchView System (K172843)Blink Device Corporation2018-03-29
EZstim*III Peripheral Nerve Stimulator/Nerve Locator (K162048)Halyard Health - Irvine2016-12-05
DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES (K051635)GE Healthcare2005-07-15
INFINITY TRIDENT NMT POD (K042003)Draeger Medical Systems, Inc.2004-09-01
NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG (K023342)Hdc Corp.2004-03-02
PNS MAGNETIC STIMULATOR SYSTEM (K002889)Neotonus, Inc.2001-04-06
TOF-WATCH S (K992596)Organon Teknika Corp.1999-08-30
TOF-WATCH SX (K992598)Organon Teknika Corp.1999-08-30
TOF-WATCH (K972698)Organon Teknika Corp.1997-12-16
AS/3 NMT MODULE (K955026)Datex Medical Instrumentation, Inc.1997-04-28
MAXISTIM (K955031)Life-Tech Intl., Inc.1996-12-10
EZ STIM (K954505)Life-Tech Intl., Inc.1996-12-10
CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION) (K953205)Fisher & Paykel Healthcare, Ltd.1996-05-23
TOF-GUARD TRANSMISSION MONITOR (K925159)Biometer Intl. A/S1993-09-01
CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272 (K924234)Fisher & Paykel Electronics , Ltd.1993-05-27
EASISTIM (K861091)Promed Corp.1986-06-02
NEUROMUSCULAR TRANSMISSION MONITOR (K840108)Datex Division Instrumentarium Corp.1984-02-17

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