CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR— 510(k) K904806

Clearance details

Applicant

Fresenius USA, Inc.

Product code

Code KDJ

Device class

Class 2

Regulation

21 CFR 876.5630

Advisory panel

Gastroenterology, Urology

Date received

1990-10-24

Decision date

1991-01-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Concord, CA, US

• K250404 — staysafe® catheter extension set with Safe- Lock, 12 inch +4 more2025-04-03
• K231849 — MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A +1 more2024-03-12
• K214016 — 15L Cycler Drainage Bag2022-03-18
• K192705 — MiniCap Extended Life PD Transfer Sets2019-10-25
• K173593 — staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch2018-05-21

• K992275 — FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS1999-08-04
• K970700 — FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX1998-09-15
• K974584 — FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS1998-05-14
• K973378 — C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 611997-11-03
• K961465 — 2008H ON LINE CLEARANCE MONITOR1997-07-03

Death

298

Injury

9,221

Malfunction

8,438

Other

1

Total

17,958

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →