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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 / K252802

510(k) cleared

Peak Flow Meter (PF-10(BR-PEF231))

Shenzhen Bi-Rich Medical Devices Co., Ltd. · May 29, 2026 · K252802

FDA cleared the Peak Flow Meter (PF-10(BR-PEF231)) from Shenzhen Bi-Rich Medical Devices Co., Ltd. on May 29, 2026 under K252802, 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 3, 2025. The decision came 268 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 Shenzhen Bi-Rich Medical Devices Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252802?

K252802 is the FDA 510(k) for Peak Flow Meter (PF-10(BR-PEF231)), submitted by Shenzhen Bi-Rich Medical Devices Co., Ltd.. FDA's decision date was May 29, 2026, under product code BZH (Meter, Peak Flow, Spirometry).

Who makes the Peak Flow Meter (PF-10(BR-PEF231))?

Shenzhen Bi-Rich Medical Devices Co., Ltd., based in Shenzhen, is the applicant of record for K252802.

How long did the K252802 review take?

FDA received the submission on Sep 3, 2025 and issued its decision on May 29, 2026, 268 days later.

← All decisions in May 2026