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FDA 510(k)

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)

K-Number: K253462 · 2026-01-29

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2026-01-29
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2026-01-29 under approval number K253462. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)?

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is a medical device that received FDA 510(k) clearance on 2026-01-29. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K253462.

When was NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) approved by the FDA?

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) received FDA 510(k) clearance on 2026-01-29, under approval number K253462.

What company makes NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)?

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.

What is the FDA product code for NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)?

The FDA product code for NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is KPO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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