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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 / K253030

510(k) cleared

Capnostream35 Portable Respiratory Monitor (PM35MN)

Covidien, LLC · May 1, 2026 · K253030

FDA cleared the Capnostream35 Portable Respiratory Monitor (PM35MN) from Covidien, LLC on May 1, 2026 under K253030, a traditional 510(k). The device falls under product code CCK, Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, regulated at 21 CFR 868.1400 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Sep 19, 2025. The decision came 224 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Covidien, LLC has 8 other decisions in the tracker over the last 12 months: K260907 (BIS Advance pEEG Module), K253527 (Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)), K253984 (Instrument Exit Point on Touch Surgery Aide), K251025 (Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)).

Questions & Answers

What did FDA clear under K253030?

K253030 is the FDA 510(k) for Capnostream35 Portable Respiratory Monitor (PM35MN), submitted by Covidien, LLC. FDA's decision date was May 1, 2026, under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase).

Who makes the Capnostream35 Portable Respiratory Monitor (PM35MN)?

Covidien, LLC, based in Lafayette, CO, is the applicant of record for K253030.

How long did the K253030 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on May 1, 2026, 224 days later.

← All decisions in May 2026