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FDA 510(k)

HemoCare Bicarbonate Concentrate Set (BCS)

K-Number: K240920 · 2024-07-12

ApplicantDeka Research and Development
Decision Date2024-07-12
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HemoCare Bicarbonate Concentrate Set (BCS) is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research and Development. It received FDA 510(k) clearance on 2024-07-12 under 510(k) number K240920. 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 HemoCare Bicarbonate Concentrate Set (BCS)?

HemoCare Bicarbonate Concentrate Set (BCS) is a medical device that received FDA 510(k) clearance on 2024-07-12. The listed applicant is Deka Research and Development. The 510(k) number is K240920.

When did HemoCare Bicarbonate Concentrate Set (BCS) receive FDA 510(k) clearance?

HemoCare Bicarbonate Concentrate Set (BCS) received FDA 510(k) clearance on 2024-07-12, under 510(k) number K240920.

Who is the listed applicant for HemoCare Bicarbonate Concentrate Set (BCS)?

The FDA 510(k) record lists Deka Research and Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HemoCare Bicarbonate Concentrate Set (BCS)?

The FDA product code for HemoCare Bicarbonate Concentrate Set (BCS) is KPO.

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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, LLCK233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLCK233213NxStage PureFlow SolutionNxstage Medical, Inc.K233159pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504Fresenius Medical Care Renal Therapies Group, LLC

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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