# K011465: Synchron CX Pro Clinical Systems, Model CX4 Pro, CX5 Pro, CX7 Pro, CX9 Pro

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 8, 2001 after 25 days
- Product code: LDP (Colorimetry, Acetaminophen)
- Device class: 2
- Regulation: 21 CFR 862.3030
- 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
- K042270: Stat K in Vitro Diagnostic Test System (2004), 0 descendants of its own

## 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/K011465
Methodology: https://510kreport.com/methodology