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FDA 510(k)

RONAVIS – FX (FX-001)

K-Number: K250315 · 2025-08-01

ApplicantAIRS, Inc.
Decision Date2025-08-01
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RONAVIS – FX (FX-001) is a medical device manufactured by AIRS, Inc.. It received FDA 510(k) clearance on 2025-08-01 under approval number K250315. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RONAVIS – FX (FX-001)?

RONAVIS – FX (FX-001) is a medical device that received FDA 510(k) clearance on 2025-08-01. It is manufactured by AIRS, Inc.. The 510(k) number is K250315.

When was RONAVIS – FX (FX-001) approved by the FDA?

RONAVIS – FX (FX-001) received FDA 510(k) clearance on 2025-08-01, under approval number K250315.

What company makes RONAVIS – FX (FX-001)?

RONAVIS – FX (FX-001) is manufactured by AIRS, Inc..

What is the FDA product code for RONAVIS – FX (FX-001)?

The FDA product code for RONAVIS – FX (FX-001) is HTY.

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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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