Chemfort Female Luer Lock Adaptor— 510(k) K251411

Substantially Equivalent

Simplivia Healthcare , Ltd.

FDA 510(k) clearance K251411 for Chemfort Female Luer Lock Adaptor, Substantially Equivalent on 2025-08-05. Applicant: Simplivia Healthcare , Ltd..

Clearance details

Applicant: Simplivia Healthcare , Ltd.
Product code: Code ONB
Advisory panel: General Hospital
Date received: 2025-05-07
Decision date: 2025-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kiryat Shmona, IL

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.