# K951496: Cell-Dyn 3500 Multi-Parameter Automated Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Oct 19, 1995 after 248 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 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
- K961439: Abbott Cell-Dyn 4000 System (1996), 7 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
- K024002: Pentra 80 (2003), 1 descendant of its own
- K012934: Cell-Dyn 3200 System with Absolute and Percent Reticulocyte (2001), 1 descendant of its own

## Recalls of this device
- Nov 30, 2009 · Not classified · Z-1698-2011: The use of the device assemblies has been extended to a 6 month useful life.

Source page: https://510kreport.com/device/K951496
Methodology: https://510kreport.com/methodology