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FDA 510(k)

Inogen Rove 4 Portable Oxygen Concentrator

K-Number: K222086 · 2022-12-09

ApplicantInogen
Decision Date2022-12-09
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Inogen Rove 4 Portable Oxygen Concentrator is a medical device manufactured by Inogen. It received FDA 510(k) clearance on 2022-12-09 under approval number K222086. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Inogen Rove 4 Portable Oxygen Concentrator?

Inogen Rove 4 Portable Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2022-12-09. It is manufactured by Inogen. The 510(k) number is K222086.

When was Inogen Rove 4 Portable Oxygen Concentrator approved by the FDA?

Inogen Rove 4 Portable Oxygen Concentrator received FDA 510(k) clearance on 2022-12-09, under approval number K222086.

What company makes Inogen Rove 4 Portable Oxygen Concentrator?

Inogen Rove 4 Portable Oxygen Concentrator is manufactured by Inogen.

What is the FDA product code for Inogen Rove 4 Portable Oxygen Concentrator?

The FDA product code for Inogen Rove 4 Portable Oxygen Concentrator is CAW.

Related Clinical Trials

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Related PubMed Literature

PMID: 41153831 Molecular Mechanisms of Thyroid Hormone Signaling in Thyroid Cancer: Oncogenesis, Progression, and Therapeutic Implications. Biomedicines (2025) PMID: 41135650 Exploration of a framework to identify cohort of concern substances in medical device risk assessment. Regulatory toxicology and pharmacology : RTP (2026) PMID: 40550854 VASN drives gastric tumorigenesis via activation of the COL4A1/PI3K/AKT axis during Helicobacter pylori infection. British journal of cancer (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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