# K962988: Coulter Gen-S System

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Oct 30, 1996 after 90 days
- Product code: GKL (Counter, Cell, Automated (Particle Counter))
- Device class: 2
- Regulation: 21 CFR 864.5200
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K885093 (1988). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K885093: Coulter STKS, Coulter Electronics, Inc. (1988) Summary page 1.
- K932030: Coulter STKS with Reticulocyte Analysis Capability, Coulter Corp. (1993) Summary page 1.

## Most influential descendants
- K022200: Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 (2002), 2 descendants of its own
- K050719: Abx Pentra DX 120: Option SPS Evolution (2005), 1 descendant of its own
- K041882: Flowcare System (2004), 1 descendant of its own
- K151133: Pentra XLR (2015), 0 descendants of its own
- K072869: Pointcare Now System (2008), 0 descendants of its own

## Recalls of this device
- Jan 31, 2011 · Not classified · Z-1956-2011: This recall was initiated because Beckman Coulter identified a problem with some date fields that are transmitted to the Laboratory Information System (LIS). Starting Jan 1, 2011, the date fields will
- Apr 18, 2007 · Not classified · Z-0315-2008: Patient Mis-identification can occur: 1)- When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is already in the To Do list. The workstation wil
- Dec 15, 2005 · Not classified · Z-0475-06: There is a risk of sample misidentification when processing samples in the Manual aspiration mode.
- Dec 10, 2002 · Not classified · Z-0571-03: Device design allows for cross contamination issue to occur, possibly affecting assays and results reports.

## Indications for use
The COULTER® GEN'S system is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The GEN-S System also provides automated Reticulocyte analysis. The COULTER GEN'S SM™ INTEGRATED SLIDEMAKER Option prepares a blood film on a clean microscope slide.

Source page: https://510kreport.com/device/K962988
Methodology: https://510kreport.com/methodology