Clearance Summary
F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) received FDA 510(k) clearance under submission number K253166, sponsored by BMC Medical 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 2026-04-29.
- Submission: K253166
- Applicant / Sponsor: BMC Medical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2026-04-29
Classification & Regulation
This clearance is catalogued under FDA product code BZD and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.