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

Name: FDA 510(k) clearance K261098
Creator: U.S. Food and Drug Administration
Published: 2026-05-22

Substantially Equivalent

Senzime AB

FDA 510(k) clearance K261098 for TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017), Substantially Equivalent on 2026-05-22. Applicant: Senzime AB. Device class: 2.

Summary

Senzime's TetraGraph Neuromuscular Transmission Monitor (SEN 2015) is filed under KOI, electric peripheral nerve stimulators. The device name also lists accessories: TetraSens (SEN 2012), TetraSens Pediatric (SEN 2013), TetraSensitive (SEN 2016) and TetraHub (SEN 2017).

Class II, 21 CFR 868.2775. Anesthesiology is both the classification panel and the review panel, and it came in as a Special 510(k).

Senzime filed from Uppsala, Sweden. Review took 50 calendar days (April 2 to May 22, 2026).

Clearance details

Applicant: Senzime AB
Product code: Product code KOI
Device class: Class 2
Regulation: 21 CFR 868.2775
Advisory panel: Anesthesiology
Date received: 2026-04-02
Decision date: 2026-05-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Uppsala, SE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.