510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802075Substantially Equivalent

Hollow Fiber Dialyzer Holder

Renal Devices, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802075 is the FDA 510(k) clearance record for HOLLOW FIBER DIALYZER HOLDER, a class II device, cleared for Renal Devices, Inc. on under FDA product code FKI (Set, Dialyzer Holder). FDA records list 4 510(k) clearances for Renal Devices, Inc., from to . As of , FDA records show no recalls naming K802075.

Clearance record

Decision date
Received
(20 days to decision)
Product code
FKI Set, Dialyzer Holder
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Renal Devices, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FKI

Trailing 12 months

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

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