HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q— 510(k) K031676

Clearance details

Applicant

Baxter Healthcare Corp

Product code

Code KDJ

Device class

Class 2

Regulation

21 CFR 876.5630

Advisory panel

Gastroenterology, Urology

Date received

2003-05-30

Decision date

2003-11-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mcgaw Park, IL, 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

• K190910 — PrisMax System Version 22019-07-25
• K163530 — PrisMax Control Unit2017-05-03
• K130531 — ULTRAFUSE2014-04-08
• K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS2013-10-08
• K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO2013-03-01

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 →