HyHub and HyHub Duo Vial Access Devices— 510(k) K243404

Substantially Equivalent

Takeda Pharmaceuticals

FDA 510(k) clearance K243404 for HyHub and HyHub Duo Vial Access Devices, Substantially Equivalent on 2025-07-18. Applicant: Takeda Pharmaceuticals.

Clearance details

Applicant: Takeda Pharmaceuticals
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2024-11-01
Decision date: 2025-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.