Atlas FDA

NIKKICART

FDA 510(k) clearance K221652 · decided 2023-03-03

Clearance details

K-number
K221652
Device name
NIKKICART
Applicant
Renal Care Dialysis Solutions, S.A. DE C.V.
Decision
Substantially Equivalent
Date received
2022-06-07
Decision date
2023-03-03
Days to decision
269 days
Clearance type
Traditional
Product code
KPO
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
El Marques, MX
Third-party review
No
Expedited review
No

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NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (K253462)Fresenius Medical Care Renal Therapies Group, LLC2026-01-29
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pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) (K233950)Fresenius Medical Care Renal Therapies Group, LLC2024-05-10
NxStage PureFlow Solution (K233213)Nxstage Medical, Inc.2024-01-18
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 (K233159)Fresenius Medical Care Renal Therapies Group, LLC2023-12-01
Citric Complete Liquid Citric Acid Concentrate (K223431)Nipro Renal Solutions USA, Corp.2023-08-04
Hemo-Lyte C Cartridge (K202508)Di-Chem, Inc.2022-08-12
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate (K212620)Fresenius Medical Care Renal Therapies Group, LLC2022-05-12
HMB32 Dialysis Solution (K212052)Haemopharm Biofluids S.R.L.2021-07-23
Nipro Dry Complete Dry Acid Concentrate for Hemodialysis (K193155)Nipro Renal Solutions USA, Corp.2020-11-25

Recalls involving this device

No recalls on record reference this clearance.