Hudson RCI Variable concentration Large Volume Nebulizer (1770)— 510(k) K220955

Substantially Equivalent

Medline Industires, Inc.

FDA 510(k) clearance K220955 for Hudson RCI Variable concentration Large Volume Nebulizer (1770), Substantially Equivalent on 2023-06-23. Applicant: Medline Industires, Inc..

Clearance details

Applicant: Medline Industires, Inc.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2022-04-01
Decision date: 2023-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfield, 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.