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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 / K253119

510(k) cleared

CoSense ETCO Monitor

Capnia, Inc. · May 29, 2026 · K253119

FDA cleared the CoSense ETCO Monitor from Capnia, Inc. on May 29, 2026 under K253119, a traditional 510(k). The device falls under product code CCJ, Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase, regulated at 21 CFR 868.1430 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Sep 24, 2025. The decision came 247 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Capnia, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253119?

K253119 is the FDA 510(k) for CoSense ETCO Monitor, submitted by Capnia, Inc.. FDA's decision date was May 29, 2026, under product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase).

Who makes the CoSense ETCO Monitor?

Capnia, Inc., based in Foster City, CA, is the applicant of record for K253119.

How long did the K253119 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on May 29, 2026, 247 days later.

← All decisions in May 2026