510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820179Substantially Equivalent

Erika Capd Prep Kit #30-9501-5

Erika, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820179 is the FDA 510(k) clearance record for ERIKA CAPD PREP KIT #30-9501-5, a class II device, cleared for Erika, Inc. on under FDA product code FKX (System, Peritoneal, Automatic Delivery). FDA records list 12 510(k) clearances for Erika, Inc., from to . As of , FDA records show no recalls naming K820179.

Clearance record

Decision date
Received
(28 days to decision)
Product code
FKX System, Peritoneal, Automatic Delivery
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Erika, Inc. 4221 Richmond Rd., NW, Walker MI
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