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FDA 510(k)

VersaPAP Positive Airway Pressure (PAP) Device

K-Number: K173918 · 2018-08-17

ApplicantTrudell Medical International
Decision Date2018-08-17
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VersaPAP Positive Airway Pressure (PAP) Device is a medical device manufactured by Trudell Medical International. It received FDA 510(k) clearance on 2018-08-17 under approval number K173918. 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 VersaPAP Positive Airway Pressure (PAP) Device?

VersaPAP Positive Airway Pressure (PAP) Device is a medical device that received FDA 510(k) clearance on 2018-08-17. It is manufactured by Trudell Medical International. The 510(k) number is K173918.

When was VersaPAP Positive Airway Pressure (PAP) Device approved by the FDA?

VersaPAP Positive Airway Pressure (PAP) Device received FDA 510(k) clearance on 2018-08-17, under approval number K173918.

What company makes VersaPAP Positive Airway Pressure (PAP) Device?

VersaPAP Positive Airway Pressure (PAP) Device is manufactured by Trudell Medical International.

What is the FDA product code for VersaPAP Positive Airway Pressure (PAP) Device?

The FDA product code for VersaPAP Positive Airway Pressure (PAP) Device is BWF.

Related Clinical Trials

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Related PubMed Literature

PMID: 42106561 Impact1: Supporting Innovation in Pediatric and Maternal Health-5 Years of Outcomes. Annals of biomedical engineering (2026) PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41079548 Clearing the airway? A pilot cadaveric study of the LifeVac™ device. Resuscitation plus (2025) PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025)

Other Devices by Trudell Medical International

K173825MC 300R* Nebulizer K173367MC 300* Nebulizer K183108Combined Aerobika OPEP and VersaPAP device K181649AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) K200063AeroEclipse* ONE BAN K203400Corrugated tube with mouthpiece accessory

View all 8 devices →

Related Devices (Code: BWF)

K160636iPEP System and vPEPD R Burton Healthcare, LLC K150044O-PEPPari Respiratory Equipment, Inc. K153441VibraPEPMedica Holdings, LLC K172388VPOD ITPRAdvanced Circulatory System, A Wholly Owned Subsidiary OF K160837MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAMMedinet Srl K163091VibraPEPMedica Holdings, 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.

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