Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)— 510(k) K192681

Substantially Equivalent

Jiangsu Kangbao Medical Equipment Co., Ltd.

FDA 510(k) clearance K192681 for Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type), Substantially Equivalent on 2020-07-28. Applicant: Jiangsu Kangbao Medical Equipment Co., Ltd..

Clearance details

Applicant: Jiangsu Kangbao Medical Equipment Co., Ltd.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2019-09-26
Decision date: 2020-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yangzhou, CN

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.