90/2 Peritoneal Dialysis System Dispos Cycler Set

by Fresenius/Delmed, Inc. 510(k)

Active United States

510(k) K903869

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK903869	Date20 Nov 1990Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number: K903869
FDA Product Code: KDJ

Device Class: Class II
Regulation: 21 CFR Part 876.5630
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

Other devices from Fresenius/Delmed, Inc.

Fresenius/Delmed 90/2 Peritoneal Dialysis System

Class II