# K944751: Coulter Flow Set

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Dec 8, 1994 after 73 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K130373: Navios Flow Cytometer System (2013), 3 descendants of its own
- K162897: Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser (2017), 2 descendants of its own
- K183592: ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer (2019), 1 descendant of its own
- K232600: DxFLEX Flow Cytometer; ClearLLab 10C Panels (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K944751
Methodology: https://510kreport.com/methodology