510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913515Substantially Equivalent

Total Containment Device

Denco, Wilmington DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913515 is the FDA 510(k) clearance record for TOTAL CONTAINMENT DEVICE, a class II device, cleared for Denco on under FDA product code KPF (System, Dialysate Delivery, Semi-Automatic, Peritoneal). FDA records list one 510(k) clearance for Denco. As of , FDA records show no recalls naming K913515.

Clearance record

Decision date
Received
(1,023 days to decision)
Product code
KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Denco P.O. Box 9600, Wilmington DE
510(k) summary
Statement
Third party review
No

Clearances, product code KPF

Trailing 12 months

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

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