510(k) K180739 ยท FPA Set, Administration, Intravascular
Clearlink System Solution Set
| Applicant | Baxter Healthcare Corporation, Round Lake IL, US |
| Decision | Substantially Equivalent, May 28, 2019 |
| Received | Mar 22, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180739
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519 Open, Classified |
FMG | None listed |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537 Open, Classified |
FMG | None listed |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Pr Open, Classified |
FMG | None listed |
| Jan 22, 2025 | Baxter Healthcare Corporation Baxter Solution Set with Duo-Vent Spike, REF 2R8404 Open, Classified |
FPA | None listed |
| Jan 22, 2025 | Baxter Healthcare Corporation Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538 Open, Classified |
FPA | None listed |
| Mar 14, 2024 | Baxter Healthcare Corporation CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401 Open, Classified |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.