510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K902149Substantially Equivalent

Fresenius/delmed 90/2 Peritoneal Dialysis System

Fresenius/Delmed, Inc., Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902149 is the FDA 510(k) clearance record for FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM, a class II device, cleared for Fresenius/Delmed, Inc. on under FDA product code FKX (System, Peritoneal, Automatic Delivery). FDA records list 2 510(k) clearances for Fresenius/Delmed, Inc., from to . As of , FDA records show no recalls naming K902149.

Clearance record

Decision date
Received
(168 days to decision)
Product code
FKX System, Peritoneal, Automatic Delivery
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fresenius/Delmed, Inc. 4090 Pike Ln., Concord CA
Third party review
No

Clearances, product code FKX

Trailing 12 months

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

FDA records show no clearances under product code FKX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FKX, 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