# K950958: Synchon CX Delta Clin Syst (CX4, CX5, CX7 Delta)

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: May 8, 1995 after 82 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 3 cite it directly.
0 of 20 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
- K965240: Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX Creatinine Picric Reagent, Synchron L (1997), 17 descendants of its own
- K042291: Unicel DXC 600 and 800 Synchron Systems (2004), 11 descendants of its own
- K183688: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), 5 descendants of its own
- K183678: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), 4 descendants of its own
- K191298: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), 4 descendants of its own

## Recalls of this device
- Aug 23, 2010 · Not classified · Z-0128-2012: 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.
- Aug 23, 2010 · Not classified · Z-0125-2012: 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.
- Aug 23, 2010 · Not classified · Z-0131-2012: 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.
- Aug 23, 2010 · Not classified · Z-0132-2012: 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/K950958
Methodology: https://510kreport.com/methodology