FDA 510(k)

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

K-Number: K253166 · 2026-04-29

Decision Date2026-04-29

Product CodeBZD

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) is the device name listed in this FDA 510(k) record. The listed applicant is BMC Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-04-29 under 510(k) 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. The listed applicant is BMC Medical Co., Ltd.. The 510(k) number is K253166.

When did F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) receive FDA 510(k) clearance?

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

Who is the listed applicant for F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)?

The FDA 510(k) record lists BMC Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03554863High Flow Oxygen in Patients Undergoing Surgery Under General AnesthesiaCOMPLETED NCT07019701Gas Composition in the Hypopharynx During High-flow or Standard Oxygen Therapy Through Face Mask in Healthy VolunteersCOMPLETED NCT07432607High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window SurgeryRECRUITING NCT07521410Non-Invasive Ventilation Interfaces and Nasal Pressure Injury in Preterm InfantsNOT_YET_RECRUITING NCT07524517NeoSHARK: Anatomical Versus Round Facemasks for Breathing Support in Preterm and Term Newborn InfantsRECRUITING NCT07558265WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency DepartmentNOT_YET_RECRUITING

Other records listing BMC Medical Co., Ltd. as applicant

K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)K242935Respiration Data Management Software (PAP Link PC)K213169BPAP System K211155Auto CPAP System K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)

Related Devices (Code: BZD)

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed Corp K254104ResScan EssentialsResmed Corp K251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation

Official Source

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