TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)

FDA 510(k) K261098 · Senzime AB

Substantially Equivalent

510(k) numberK261098

Submission

Device name
TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)
Applicant
Senzime AB
Uppsala, SE
Received
April 2, 2026
Decision date
May 22, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KOI – Stimulator, Nerve, Peripheral, Electric
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2775
Specialty
Anesthesiology

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K250887Neuromuscular Transmission Monitor TOF3D (2510091)KOI · Traditional MIPM Mammendorfer Institut für Physik und…10/21/2025SE
K243339WiTOFKOI · Traditional Idmed06/23/2025SE
K242525iTOF®KOI · Traditional Nerbio Medical Software Platforms, Inc.12/05/2024SE
K220530Tetragraph Neuromuscular Transmission MonitorKOI · Traditional Senzime AB08/17/2022SE
K220976Life Scope PT BSM-1700 Series Bedside MonitorKOI · Special Nihon Kohden Corporation07/21/2022SE
K212434Neuromuscular Transmission Monitor TOF3DKOI · Traditional MIPM Mammendorfer Institut für Physik und…05/05/2022SE
K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000…KOI · Special Nihon Kohden Corporation12/29/2021SE
K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM…KOI · Traditional Nihon Kohden Corporation05/02/2021SE
K192958TwitchView SystemKOI · Special Blink Device Company04/02/2020SE
K190795Tetragraph Neuromuscular Transmission MonitorKOI · Traditional Senzime AB10/18/2019SE

More from Senzime AB

510(k)DeviceDecision
K220530Tetragraph Neuromuscular Transmission MonitorKOI · Traditional 08/17/2022SE
K190795Tetragraph Neuromuscular Transmission MonitorKOI · Traditional 10/18/2019SE

Questions and answers

When was TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) cleared by the FDA?

TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) (K261098) received a 510(k) decision of Substantially Equivalent on May 22, 2026, 50 days after the submission was received.

What is the product code of K261098?

The FDA product code is KOI – Stimulator, Nerve, Peripheral, Electric, a Class II (moderate risk) device regulated under 21 CFR 868.2775.