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FDA 510(k)

AirPhysio Positive Expiratory Pressure (PEP) Device

K-Number: K203209 · 2021-01-15

ApplicantAirphysio Pty, Ltd.
Decision Date2021-01-15
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AirPhysio Positive Expiratory Pressure (PEP) Device is a medical device manufactured by Airphysio Pty, Ltd.. It received FDA 510(k) clearance on 2021-01-15 under approval number K203209. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AirPhysio Positive Expiratory Pressure (PEP) Device?

AirPhysio Positive Expiratory Pressure (PEP) Device is a medical device that received FDA 510(k) clearance on 2021-01-15. It is manufactured by Airphysio Pty, Ltd.. The 510(k) number is K203209.

When was AirPhysio Positive Expiratory Pressure (PEP) Device approved by the FDA?

AirPhysio Positive Expiratory Pressure (PEP) Device received FDA 510(k) clearance on 2021-01-15, under approval number K203209.

What company makes AirPhysio Positive Expiratory Pressure (PEP) Device?

AirPhysio Positive Expiratory Pressure (PEP) Device is manufactured by Airphysio Pty, Ltd..

What is the FDA product code for AirPhysio Positive Expiratory Pressure (PEP) Device?

The FDA product code for AirPhysio Positive Expiratory Pressure (PEP) Device is BYI.

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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: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025)

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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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