# K885028: Coulter 5P Control

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Electronics, Inc.
- Decided: Feb 16, 1989 after 73 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- 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/K885028
Methodology: https://510kreport.com/methodology