510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K872221Substantially Equivalent

Dialy-Nate Set & Dialy-Nate Catheter

Gesco Intl., Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872221 is the FDA 510(k) clearance record for DIALY-NATE SET & DIALY-NATE CATHETER, a class II device, cleared for Gesco Intl., Inc. on under FDA product code FKO (Catheter, Peritoneal Dialysis, Single Use). FDA records list 26 510(k) clearances for Gesco Intl., Inc., from to . As of , FDA records show no recalls naming K872221.

Clearance record

Decision date
Received
(126 days to decision)
Product code
FKO Catheter, Peritoneal Dialysis, Single Use
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gesco Intl., Inc. P.O. Box 690188, San Antonio TX
Third party review
No

Clearances, product code FKO

Trailing 12 months

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

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