# K870603: System 9000 Automated Cell Counter

- Pathway: 510(k) (Traditional)
- Applicant: Baker Instructions Corp.
- Decided: Mar 31, 1987 after 48 days
- Product code: GKL (Counter, Cell, Automated (Particle Counter))
- Device class: 2
- Regulation: 21 CFR 864.5200
- 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
- K953598: Series 9100 Plus Automated Differential Hematology Analyzers (1996), 3 descendants of its own
- K022200: Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 (2002), 2 descendants of its own
- K050719: Abx Pentra DX 120: Option SPS Evolution (2005), 1 descendant of its own
- K151133: Pentra XLR (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K870603
Methodology: https://510kreport.com/methodology