FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR— 510(k) K022412
Substantially EquivalentFresenius Medical Care North America
FDA 510(k) clearance K022412 for FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR, Substantially Equivalent on 2003-03-05. Applicant: Fresenius Medical Care North America. Device class: 2.
Clearance details
- Applicant
- Fresenius Medical Care North America
- 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
- Lexington, MA, 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
More clearances from Fresenius Medical Care North America
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 K022412
K-number listed on FDA's recall record- Z-1323-2024 — stay-safe /Safe Lock Catheter Ext. 12 in
- Z-1324-2024 — stay-safe /Luer Lock Adapter 4 in
- Z-1325-2024 — stay-safe /Luer Lock Catheter Ext. 12 in
- Z-1326-2024 — stay-safe /Luer Lock Catheter Ext. 18 in
- Z-1327-2024 — stay-safe /Luer Catheter Ext. 6 in
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022412.
Data sourced from openFDA. This site is unofficial and independent of the FDA.