AquaCast Mask
FDA 510(k) K252174 · Blessing Cathay Corporation
510(k) numberK252174
Submission
- Device name
- AquaCast Mask
- Applicant
- Blessing Cathay Corporation
New Taipei City, TW - Received
- July 11, 2025
- Decision date
- September 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253012 | AlignRT Plus (8.0)IYE · Traditional | Vision Rt, Ltd. | 03/18/2026SE |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | Varian Medical Systems, Inc. | 01/21/2026SE |
Questions and answers
When was AquaCast Mask cleared by the FDA?
AquaCast Mask (K252174) received a 510(k) decision of Substantially Equivalent on September 3, 2025, 54 days after the submission was received.
What is the product code of K252174?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.