# K201009: CHIRAVAC Blood Collection Needles

- Pathway: 510(k) (Traditional)
- Applicant: Chirana T. Injecta
- Decided: Jul 21, 2021 after 460 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)
- K182146: Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set, Sol-Millennium Medical, Inc. (2018) Summary page 5.

## Indications for use
The CHIRAVAC™ Blood Collection Needles are single use and are intended for venous blood collection in connection with blood collection tubes.

Source page: https://510kreport.com/device/K201009
Methodology: https://510kreport.com/methodology