# K250961: Blood collection tube holders

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Jun 4, 2025 after 65 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K972404 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230080: Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood, Yangzhou Medline Industry, Co., Ltd. (2023) Summary page 5.

## Indications for use
It is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. It is for adult use only.

Source page: https://510kreport.com/device/K250961
Methodology: https://510kreport.com/methodology