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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K261098

510(k) cleared

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

Senzime AB · May 22, 2026 · K261098

FDA cleared the TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) from Senzime AB on May 22, 2026 under K261098, a special 510(k). The device falls under product code KOI, Stimulator, Nerve, Peripheral, Electric, regulated at 21 CFR 868.2775 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Apr 2, 2026. The decision came 50 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Senzime AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261098?

K261098 is the FDA 510(k) for TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017), submitted by Senzime AB. FDA's decision date was May 22, 2026, under product code KOI (Stimulator, Nerve, Peripheral, Electric).

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

Senzime AB, based in Uppsala, is the applicant of record for K261098.

How long did the K261098 review take?

FDA received the submission on Apr 2, 2026 and issued its decision on May 22, 2026, 50 days later.

← All decisions in May 2026