Eclipse Blood Collection Set— 510(k) K213690

Substantially Equivalent

Eclipse Medcorp, LLC

FDA 510(k) clearance K213690 for Eclipse Blood Collection Set, Substantially Equivalent on 2022-10-26. Applicant: Eclipse Medcorp, LLC.

Clearance details

Applicant: Eclipse Medcorp, LLC
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2021-11-23
Decision date: 2022-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: The Colony, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.