freeflex+ Transfer Adapter— 510(k) K212445

Substantially Equivalent

Fresenius Kabi AG

FDA 510(k) clearance K212445 for freeflex+ Transfer Adapter, Substantially Equivalent on 2022-06-01. Applicant: Fresenius Kabi AG.

Clearance details

Applicant: Fresenius Kabi AG
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2021-08-05
Decision date: 2022-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bad Homburg, DE

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.