K172763

Substantially Equivalent

Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder

Applicant: Zhejiang Kindly Medical Devices Co., Ltd.
Product code: JKA
Advisory panel: Clinical Chemistry
Date received: 2017-09-13
Decision date: 2018-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wenzhou, 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.