BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)— 510(k) K250059

Substantially Equivalent

Becton, Dickinson and Company

FDA 510(k) clearance K250059 for BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O), Substantially Equivalent on 2025-09-12. Applicant: Becton, Dickinson and Company.

Clearance details

Applicant: Becton, Dickinson and Company
Product code: Code ONB
Advisory panel: General Hospital
Date received: 2025-01-10
Decision date: 2025-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ONB

product code ONB

Malfunction: 3,615
Other: 13
Total: 3,628

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.