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— 510(k) K172763

Clearance details

Applicant

Zhejiang Kindly Medical Devices Co., Ltd.

Product code

Code JKA

Device class

Class 2

Regulation

21 CFR 862.1675

Advisory panel

Clinical Chemistry

Date received

2017-09-13

Decision date

2018-06-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wenzhou, CN

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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 →