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FDA 510(k)

AF531 Oro-Nasal SE Face Mask

K-Number: K243394 · 2024-12-30

ApplicantRespironics, Inc.
Decision Date2024-12-30
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AF531 Oro-Nasal SE Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2024-12-30 under 510(k) number K243394. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AF531 Oro-Nasal SE Face Mask?

AF531 Oro-Nasal SE Face Mask is a medical device that received FDA 510(k) clearance on 2024-12-30. The listed applicant is Respironics, Inc.. The 510(k) number is K243394.

When did AF531 Oro-Nasal SE Face Mask receive FDA 510(k) clearance?

AF531 Oro-Nasal SE Face Mask received FDA 510(k) clearance on 2024-12-30, under 510(k) number K243394.

Who is the listed applicant for AF531 Oro-Nasal SE Face Mask?

The FDA 510(k) record lists Respironics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AF531 Oro-Nasal SE Face Mask?

The FDA product code for AF531 Oro-Nasal SE Face Mask is CBK.

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 AnesthesiaCOMPLETEDNCT07019701Gas Composition in the Hypopharynx During High-flow or Standard Oxygen Therapy Through Face Mask in Healthy VolunteersCOMPLETEDNCT07432607High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window SurgeryRECRUITINGNCT07558265WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency DepartmentNOT_YET_RECRUITINGNCT07718295HFNO Versus Face Mask for Cerebral Oxygenation During Procedural SedationRECRUITINGNCT07723430Comparison of High-Flow Nasal Cannula and Tight Face Mask for Maintaining Oxygenation During Rapid Sequence InductionNOT_YET_RECRUITING

Other records listing Respironics, Inc. as applicant

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.

K231313Therapy Mask 3100 NC/SPK210844DreamWear Silicone Pillows MaskK210386Magneto Nasal MaskK202142Sleepware G3K201439Ventilator, Non-continuous (Respirator)K200480DreamStation 2 System, DreamStation 2 Advanced System

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Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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.

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