# K912133: PX Coulter (R) Cell Control

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Electronics, Inc.
- Decided: Jul 17, 1991 after 64 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 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
- K060464: Coulter 5C Cell Control (2006), 5 descendants of its own
- K081822: Coulter 6C Cell Control, Models 628027 & A59925 (2009), 3 descendants of its own
- K181599: Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application (2019), 2 descendants of its own
- K193124: Unicel DxH 800 Coulter Cellular Analysis System (2020), 1 descendant of its own
- K240252: UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K912133
Methodology: https://510kreport.com/methodology