MiniCap Extended Life PD Transfer Sets— 510(k) K192705
Substantially EquivalentBaxter Healthcare
FDA 510(k) clearance K192705 for MiniCap Extended Life PD Transfer Sets, Substantially Equivalent on 2019-10-25. 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
- Special
- 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
- 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
- K173651 — Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
More clearances from Baxter Healthcare
view allAdverse 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 K192705
K-number listed on FDA's recall record- Z-0562-2025 — Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
- Z-0376-2025 — Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
- Z-0768-2021 — MiniCap Extended Life PD Transfer Set
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192705.
Data sourced from openFDA. This site is unofficial and independent of the FDA.