Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)

K-Number: K253166 · 2026-04-29

ApplicantBMC Medical Co., Ltd.
Decision Date2026-04-29
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) is a medical device manufactured by BMC Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-04-29 under approval number K253166. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)?

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) is a medical device that received FDA 510(k) clearance on 2026-04-29. It is manufactured by BMC Medical Co., Ltd.. The 510(k) number is K253166.

When was F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) approved by the FDA?

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) received FDA 510(k) clearance on 2026-04-29, under approval number K253166.

What company makes F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)?

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) is manufactured by BMC Medical Co., Ltd..

What is the FDA product code for F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)?

The FDA product code for F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) is BZD.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑