# K922704: Coulter Maxm W/ Autoloader

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Electronics, Inc.
- Decided: Jul 27, 1992 after 52 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.
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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K042173: Coulter a T 5DIFF Cap Pierce (CP) (2004), 0 descendants of its own

## Recalls of this device
- Oct 13, 2011 · Not classified · Z-0602-2012: The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer.

Source page: https://510kreport.com/device/K922704
Methodology: https://510kreport.com/methodology