Clearance Summary
Peak Flow Meter (PF-10(BR-PEF231)) received FDA 510(k) clearance under submission number K252802, sponsored by Shenzhen Bi-Rich Medical Devices Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-05-29.
- Submission: K252802
- Applicant / Sponsor: Shenzhen Bi-Rich Medical Devices Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1860
- Decision date: 2026-05-29
Classification & Regulation
This clearance is catalogued under FDA product code BZH and 21 CFR 868.1860, within the Anesthesiology review panel as a Class II device.