510(k) K261470
K261470 is an FDA 510(k) premarket notification submitted by E.A.M Benelux B.V for the device "QF10". The FDA issued a decision of Substantially Equivalent on September 9, 2026. The device falls under product code NHV (System, Water Purification, General Medical Use), a Class II device regulated under 21 CFR 876.5665.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2026
- Date Received
- May 4, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Water Purification, General Medical Use
- Device Class
- Class II
- Regulation Number
- 876.5665
- Review Panel
- GU
- Submission Type
The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists. Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing.