NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)— 510(k) K253462
Substantially EquivalentFresenius Medical Care Renal Therapies Group, LLC
FDA 510(k) clearance K253462 for NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2), Substantially Equivalent on 2026-01-29. Applicant: Fresenius Medical Care Renal Therapies Group, LLC. Device class: 2.
Clearance details
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- Product code
- Code KPO
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Recent devices under product code KPO
view all- K260799 — Nipro Dry Acid Concentrate Mixer
- K252180 — Bicarby Dialysate RFP-404 (RFP-404-W) +7 more
- K243786 — Bicarby Dialysate RFP-402 (RFP-402-G) +7 more
- K240920 — HemoCare Bicarbonate Concentrate Set (BCS)
- K233950 — pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
More clearances from Fresenius Medical Care Renal Therapies Group, LLC
view allAdverse events under product code KPO
product code KPO- Death
- 14
- Malfunction
- 775
- Other
- 20
- Total
- 809
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.