Hudson RCI® TurboMist Nebulizer System— 510(k) K230602

Substantially Equivalent

Medline Industries, LP

FDA 510(k) clearance K230602 for Hudson RCI® TurboMist Nebulizer System, Substantially Equivalent on 2023-10-31. Applicant: Medline Industries, LP.

Clearance details

Applicant: Medline Industries, LP
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2023-03-03
Decision date: 2023-10-31
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.