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

FDA 510(k)

Hudson RCI Triflo II Incentive Deep Breathing Exerciser

K-Number: K220565 · 2022-10-25

ApplicantMedline Industries, Inc.
Decision Date2022-10-25
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Hudson RCI Triflo II Incentive Deep Breathing Exerciser is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2022-10-25 under 510(k) number K220565. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hudson RCI Triflo II Incentive Deep Breathing Exerciser?

Hudson RCI Triflo II Incentive Deep Breathing Exerciser is a medical device that received FDA 510(k) clearance on 2022-10-25. The listed applicant is Medline Industries, Inc.. The 510(k) number is K220565.

When did Hudson RCI Triflo II Incentive Deep Breathing Exerciser receive FDA 510(k) clearance?

Hudson RCI Triflo II Incentive Deep Breathing Exerciser received FDA 510(k) clearance on 2022-10-25, under 510(k) number K220565.

Who is the listed applicant for Hudson RCI Triflo II Incentive Deep Breathing Exerciser?

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

What is the FDA product code for Hudson RCI Triflo II Incentive Deep Breathing Exerciser?

The FDA product code for Hudson RCI Triflo II Incentive Deep Breathing Exerciser is BWF.

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.

NCT07613892Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure AdhesivesCOMPLETEDNCT07734220Evaluation of Two Heel Protection Devices to Assess Off-loading Via Pressure Mapping.COMPLETEDNCT06688422Incentive Spirometry to Improve Outcomes in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation TherapyRECRUITINGNCT07435532Comparative Effects of Breather Device and Incentive Spirometer in Patients With COPDNOT_YET_RECRUITINGNCT07728214Reminder-enhanced Incentive Spirometry EvaluationNOT_YET_RECRUITING

Other records listing Medline Industries, 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.

K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)K222665Medline UNITE® Ankle Fusion Plating SystemK213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeK212911Konig Mogen ClampK213481Medline General Surgery Tray

View all 74 devices →

Related Devices (Code: BWF)

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.

K241152InSeeTidal Medical Technologies, LLCK233855AllPEPEnchant Tek Co. , Ltd.K221058LungTrainer (MD2 & MD3)Lung Trainers, LLCK222018Breathe+Peep Medical, LLC Dba Go2 DevicesK203378PulsehalerRespinova, Ltd.K192000D R Burton OxyPAPD R Burton Healthcare, LLC

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.

↑