Cleared Special

TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) (K261098) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K261098 · Senzime AB · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
50d
Days
Class 2
Risk

K261098 is an FDA 510(k) clearance for the TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens.... Classified as Stimulator, Nerve, Peripheral, Electric (product code KOI), Class II - Special Controls.

Submitted by Senzime AB (Uppsala, SE). The FDA issued a Cleared decision on May 22, 2026 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Senzime AB devices

Submission Details

510(k) Number K261098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2026
Decision Date May 22, 2026
Days to Decision 50 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 139d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KOI Stimulator, Nerve, Peripheral, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

Obelix Consulting, LLC
Elisa Maldonado-Holmertz

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KOI Stimulator, Nerve, Peripheral, Electric

All 13
Devices cleared under the same product code (KOI) and FDA review panel - the closest regulatory comparables to K261098.
Neuromuscular Transmission Monitor TOF3D (2510091)
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iTOF®
K242525 · Nerbio Medical Software Platforms, Inc. · Dec 2024
Tetragraph Neuromuscular Transmission Monitor
K220530 · Senzime AB · Aug 2022
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K220976 · Nihon Kohden Corporation · Jul 2022
Neuromuscular Transmission Monitor TOF3D
K212434 · MIPM Mammendorfer Institut f?r Physik und Medizin GmbH · May 2022