# K904220: Synchron CX4-CE

- Pathway: 510(k) (Traditional)
- Applicant: Beckman
- Decided: Oct 15, 1990 after 33 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K971505: Synchron Systems Cholesterol (Chol) Reagent (1997), 0 descendants of its own

## Recalls of this device
- Aug 23, 2010 · Not classified · Z-0126-2012: The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems.

Source page: https://510kreport.com/device/K904220
Methodology: https://510kreport.com/methodology