Blood collection tube holders— 510(k) K250961

Substantially Equivalent

Promisemed Hangzhou Meditech Co., Ltd.

FDA 510(k) clearance K250961 for Blood collection tube holders, Substantially Equivalent on 2025-06-04. Applicant: Promisemed Hangzhou Meditech Co., Ltd..

Clearance details

Applicant: Promisemed Hangzhou Meditech Co., Ltd.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2025-03-31
Decision date: 2025-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou City, 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.