15L Cycler Drainage Bag— 510(k) K214016

Substantially Equivalent

Baxter Healthcare Corporation

FDA 510(k) clearance K214016 for 15L Cycler Drainage Bag, Substantially Equivalent on 2022-03-18. Applicant: Baxter Healthcare Corporation.

Clearance details

Applicant: Baxter Healthcare Corporation
Product code: Code KDJ
Advisory panel: Gastroenterology, Urology
Date received: 2021-12-22
Decision date: 2022-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield Lake, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDJ

product code KDJ

Death: 298
Injury: 9,221
Malfunction: 8,438
Other: 1
Total: 17,958

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.