Hudson RCI® AddiPak® Unit Dose Vial— 510(k) K231058

Substantially Equivalent

Medline Industries, LP

FDA 510(k) clearance K231058 for Hudson RCI® AddiPak® Unit Dose Vial, Substantially Equivalent on 2024-01-04. Applicant: Medline Industries, LP.

Clearance details

Applicant: Medline Industries, LP
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2023-04-13
Decision date: 2024-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfiled, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.