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FDA 510(k)

AquaCast Mask

K-Number: K252174 · 2025-09-03

ApplicantBlessing Cathay Corporation
Decision Date2025-09-03
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AquaCast Mask is a medical device manufactured by Blessing Cathay Corporation. It received FDA 510(k) clearance on 2025-09-03 under approval number K252174. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AquaCast Mask?

AquaCast Mask is a medical device that received FDA 510(k) clearance on 2025-09-03. It is manufactured by Blessing Cathay Corporation. The 510(k) number is K252174.

When was AquaCast Mask approved by the FDA?

AquaCast Mask received FDA 510(k) clearance on 2025-09-03, under approval number K252174.

What company makes AquaCast Mask?

AquaCast Mask is manufactured by Blessing Cathay Corporation.

What is the FDA product code for AquaCast Mask?

The FDA product code for AquaCast Mask is IYE.

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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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