Atlas FDA

MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION

FDA 510(k) clearance K053286 · decided 2005-12-22

Clearance details

K-number
K053286
Device name
MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION
Applicant
Nxstage Medical, Inc.
Decision
Substantially Equivalent
Date received
2005-11-25
Decision date
2005-12-22
Days to decision
27 days
Clearance type
Special
Product code
KPO
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Lawrence, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Nxstage Medical

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (K253462)Fresenius Medical Care Renal Therapies Group, LLC2026-01-29
Bicarby 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) (K252180)Fresenius Medical Care Renal Therapies Group, LLC2025-09-09
Bicarby 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) (K243786)Fresenius Medical Care Renal Therapies Group, LLC2025-04-04
HemoCare Bicarbonate Concentrate Set (BCS) (K240920)Deka Research and Development2024-07-12
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
NIKKICART (K221652)Renal Care Dialysis Solutions, S.A. DE C.V.2023-03-03
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

Recalls involving this device

RecordFirmDate
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, recall (Z-1864-2025)NxStage Medical Inc2025-05-28
NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers R recall (Z-2160-2024)NxStage Medical Inc2024-06-20
NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case recall (Z-1073-2014)NxStage Medical, Inc.2014-02-24