510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243371Substantially Equivalent

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1

Byonyks Pvt Ltd, Lahore, PK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243371 is the FDA 510(k) clearance record for Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1, a class II device, cleared for Byonyks Pvt, Ltd. on under FDA product code FKX (System, Peritoneal, Automatic Delivery). FDA records list one 510(k) clearance for Byonyks Pvt, Ltd. As of , FDA records show no recalls naming K243371.

Clearance record

Decision date
Received
(198 days to decision)
Product code
FKX System, Peritoneal, Automatic Delivery
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Byonyks Pvt, Ltd. 45/A Xx Block Khayban-E-Iqbal, Lahore, PK
510(k) summary
Summary PDF
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