510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901478Substantially Equivalent

Delmed 80/2 Dialysis System W/last Bag Option

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

K901478 is the FDA 510(k) clearance record for DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION, a class II device, cleared for Delmed, Inc. on under FDA product code FKX (System, Peritoneal, Automatic Delivery). FDA records list 27 510(k) clearances for Delmed, Inc., from to . As of , FDA records show no recalls naming K901478.

Clearance record

Decision date
Received
(122 days to decision)
Product code
FKX System, Peritoneal, Automatic Delivery
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
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