Home / 510(k) Clearances / K971053

510(k) K971053

ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS by International Medical Products, Inc. — Product Code KPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1997
Date Received
March 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by International Medical Products, Inc.

  • K981069 — ULTRA-COVER PU-TRANSDUCER COVER (September 23, 1998)
  • K981003 — ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES (June 16, 1998)
  • K973253 — ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE (October 30, 1997)
  • K920077 — NIKKISO NK PUMP (September 29, 1993)
  • K923942 — RHOMBO MEDICAL RHOMBO-FILL (March 24, 1993)
  • K900755 — DIGITAL CUFF PV GAUGE (April 26, 1990)
  • K864984 — ROBINJECT (June 29, 1987)
  • K863609 — SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 (February 25, 1987)
  • K861539 — NIKKISO INFUSION PUMP MODEL PFA-02 (July 31, 1986)

Other clearances for product code KPO

  • K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (January 29, 2026)
  • K252180 — Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bi (September 9, 2025)
  • K243786 — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bi (April 4, 2025)
  • K240920 — HemoCare Bicarbonate Concentrate Set (BCS) (July 12, 2024)
  • K233950 — pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pu (May 10, 2024)
  • K233213 — NxStage PureFlow Solution (January 18, 2024)
  • K233159 — pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 5 (December 1, 2023)
  • K223431 — Citric Complete Liquid Citric Acid Concentrate (August 4, 2023)
  • K221652 — NIKKICART (March 3, 2023)
  • K202508 — Hemo-Lyte C Cartridge (August 12, 2022)