510(k) K253462
K253462 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)". The FDA issued a decision of Substantially Equivalent on January 29, 2026. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Fresenius Medical Care Renal Therapies Group, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2026
- Date Received
- October 7, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type