510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862928Substantially Equivalent

Amukin-50% for Capd Y-Set

Amuchina Intl., Inc., Silver Spring MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862928 is the FDA 510(k) clearance record for AMUKIN-50% FOR CAPD Y-SET, a class II device, cleared for Amuchina Intl., Inc. on under FDA product code FKX (System, Peritoneal, Automatic Delivery). FDA records list 5 510(k) clearances for Amuchina Intl., Inc., from to . As of , FDA records show no recalls naming K862928.

Clearance record

Decision date
Received
(220 days to decision)
Product code
FKX System, Peritoneal, Automatic Delivery
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Amuchina Intl., Inc. 12120a Heritage Park Cir., Silver Spring MD
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