Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate

K-Number: K192209 · 2020-05-08

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2020-05-08
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2020-05-08 under 510(k) number K192209. 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 Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate?

Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate is a medical device that received FDA 510(k) clearance on 2020-05-08. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K192209.

When did Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate receive FDA 510(k) clearance?

Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate received FDA 510(k) clearance on 2020-05-08, under 510(k) number K192209.

Who is the listed applicant for Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate?

The FDA 510(k) record lists Fresenius Medical Care Renal Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate?

The FDA product code for Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate is KPO.

Other records listing Fresenius Medical Care Renal Therapies Group, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261267Careflux H60;Careflux H70;Careflux V500K252377NxStage System One with NxViewK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)K253518FX CorAL 40; FX CorAL 50K250634BCM2-Body Composition Monitor

View all 48 devices →

Related Devices (Code: KPO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLCK252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLCK243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLCK240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and DevelopmentK233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLCK233213NxStage PureFlow SolutionNxstage Medical, Inc.

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.

↑