DRI-LYTE— 510(k) K780353

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K780353 for DRI-LYTE, Substantially Equivalent on 1978-04-05. Applicant: Mallinckrodt Critical Care.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 1978-03-03
Decision date: 1978-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

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.