APD LUER-LOCK ADAPTER— 510(k) K124024
Substantially EquivalentFresensius Medical Care North America
FDA 510(k) clearance K124024 for APD LUER-LOCK ADAPTER, Substantially Equivalent on 2013-09-19. Applicant: Fresensius Medical Care North America. Device class: 2.
Clearance details
- Applicant
- Fresensius 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
- Waltham, 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
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 K124024
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K124024.
Data sourced from openFDA. This site is unofficial and independent of the FDA.