EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER— 510(k) K152675
Substantially EquivalentBaxter Healthcare
FDA 510(k) clearance K152675 for EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER, Substantially Equivalent on 2015-10-29. Applicant: Baxter Healthcare. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare
- Product code
- Code KDJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Round Lake, IL, US
Recent devices under product code KDJ
view all- K250404 — staysafe® catheter extension set with Safe- Lock, 12 inch +4 more
- K231849 — MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A +1 more
- K214016 — 15L Cycler Drainage Bag
- K192705 — MiniCap Extended Life PD Transfer Sets
- 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 inch
Adverse events under product code KDJ
product code KDJ- Death
- 298
- Injury
- 9,221
- Malfunction
- 8,438
- Other
- 1
- Total
- 17,958
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K152675
K-number listed on FDA's recall record- Z-0559-2025 — Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
- Z-0373-2025 — Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
- Z-0570-2022 — Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
- Z-0571-2022 — Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482
- Z-0572-2022 — Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
- Z-0573-2022 — Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ
- Z-0574-2022 — Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S
- Z-0575-2022 — Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482
- Z-0576-2022 — Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
- Z-0577-2022 — Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483
- Z-0578-2022 — Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484
- Z-0579-2022 — Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482
- Z-0580-2022 — Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152675.
Data sourced from openFDA. This site is unofficial and independent of the FDA.