510(k) K250514
K250514 is an FDA 510(k) premarket notification submitted by Specialty Water Technologies, Inc. for the device "UPT Series Medical RO Water Treatment System". The FDA issued a decision of Substantially Equivalent on March 17, 2025. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Specialty Water Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2025
- Date Received
- February 21, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Subsystem, Water Purification
- Device Class
- Class II
- Regulation Number
- 876.5665
- Review Panel
- GU
- Submission Type