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FDA 510(k)

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)

K-Number: K251611 · 2025-06-25

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2025-06-25
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2025-06-25 under 510(k) number K251611. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)?

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K251611.

When did Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) receive FDA 510(k) clearance?

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) received FDA 510(k) clearance on 2025-06-25, under 510(k) number K251611.

Who is the listed applicant for Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)?

The FDA 510(k) record lists Fisher & Paykel Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)?

The FDA product code for Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) is BTT.

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.

NCT07133698High Flow Nasal Cannula Versus High Velocity Nasal Insufflation for WeaningCOMPLETEDNCT05691218Early High-flow Oxygen Therapy With nebuLized Beta-2-agonist Using a Vibrating Mesh for the Management of Moderate to Severe Asthma Exacerbation in the Emergency DepartmentRECRUITINGNCT05754034Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen EvaluationRECRUITINGNCT07515716Effects of High Flow Humidified Oxygen on Umbilical Artery Acid-base Balance in Cesarean Section Under Spinal AnesthesiaNOT_YET_RECRUITINGNCT07613762High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac RehabilitationNOT_YET_RECRUITINGNCT07722377Effect of Continuous Nebulisation of Isotonic Saline Solution Combined With Heated Humidification on Mucociliary Clearance in Healthy SubjectsNOT_YET_RECRUITING

Other records listing Fisher & Paykel Healthcare, Ltd. 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.

K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)K250651OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP JunK252173F&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 FullK243917F&P Optiflow Air/Oxygen Flow SourceK243583F&P Nova Nasal MaskK234053F&P Optiflow Flow Diverter

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Related Devices (Code: BTT)

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.

K254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LPK242717Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.

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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