# K951189: Synchron CX4CE/CX5CE/CX7 Clinical Systems Software Update Version 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Jun 13, 1995 after 89 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Sep 29, 2003 · Not classified · Z-0067-04: Motor driver boards may contain wrong type of microchip which does not have obstruction detection feature.

Source page: https://510kreport.com/device/K951189
Methodology: https://510kreport.com/methodology