510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954623Substantially Equivalent

Redy 2000 System (Therapeutic Plasma Exchange Option and Monitoring Line Y-Connector)

Gambro Healthcare, Oklahoma City OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954623 is the FDA 510(k) clearance record for REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR), a class II device, cleared for Gambro Healthcare on under FDA product code FKT (System, Dialysate Delivery, Sorbent Regenerated). FDA records list 13 510(k) clearances for Gambro Healthcare, from to . As of , FDA records show no recalls naming K954623.

Clearance record

Decision date
Received
(328 days to decision)
Product code
FKT System, Dialysate Delivery, Sorbent Regenerated
Regulation
21 CFR 876.5600
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gambro Healthcare 3631 SW 54th St., Oklahoma City OK
510(k) summary
Statement
Third party review
No

Clearances, product code FKT

Trailing 12 months

FDA records hold no clearances under product code FKT in the trailing twelve months.

FDA records show no clearances under product code FKT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FKT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260