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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 / June 2026 / K253180

510(k) cleared

Microlife Digital Peak Flow Meter, Model PF200B (PF200B)

Microlife Corporation · Jun 23, 2026 · K253180

FDA cleared the Microlife Digital Peak Flow Meter, Model PF200B (PF200B) from Microlife Corporation on Jun 23, 2026 under K253180, a traditional 510(k). The device falls under product code BZH, Meter, Peak Flow, Spirometry, regulated at 21 CFR 868.1860 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Sep 26, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Microlife Corporation has one other decision in the tracker over the last 12 months: K261082 (Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)).

Questions & Answers

What did FDA clear under K253180?

K253180 is the FDA 510(k) for Microlife Digital Peak Flow Meter, Model PF200B (PF200B), submitted by Microlife Corporation. FDA's decision date was Jun 23, 2026, under product code BZH (Meter, Peak Flow, Spirometry).

Who makes the Microlife Digital Peak Flow Meter, Model PF200B (PF200B)?

Microlife Corporation, based in Taipei, is the applicant of record for K253180.

How long did the K253180 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jun 23, 2026, 270 days later.

← All decisions in June 2026

Sources