Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood— 510(k) K230080

Substantially Equivalent

Yangzhou Medline Industry, Co., Ltd.

FDA 510(k) clearance K230080 for Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood, Substantially Equivalent on 2023-07-07. Applicant: Yangzhou Medline Industry, Co., Ltd..

Clearance details

Applicant: Yangzhou Medline Industry, Co., Ltd.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2023-01-11
Decision date: 2023-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yangzhou, CN

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.