EXTENDED LIFE CAPD TRANSFER SET 5C4444— 510(k) K882498

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

1988-06-17

Decision date

1988-07-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Round Lake, 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 →

• Z-2246-2017 — Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USAClass II·Terminated·Baxter Healthcare Corporation·20140428
• Z-2471-2015 — MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.Class II·Terminated·Baxter Healthcare Corp.·20130225
• Z-2472-2015 — MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.Class II·Terminated·Baxter Healthcare Corp.·20130225
• Z-2473-2015 — MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.Class II·Terminated·Baxter Healthcare Corp.·20130225
• Z-2474-2015 — CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solution.Class II·Terminated·Baxter Healthcare Corp.·20130225

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K882498.