510(k) · Cleared
Recalled · 2011Coulter Gen-S System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coulter Corp. · GKL Counter, Cell, Automated (Particle Counter)
Cleared on Oct 30, 1996 as substantially equivalent to K885093 (Coulter Electronics, Inc., 1988) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1988. 6 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 30, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- GKL
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 1 generation to K885093 (1988). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK885093 Coulter STKSCoulter Electronics, Inc. · 1988
- This deviceK962988 Coulter Gen-S SystemCoulter Corp. · 1996
- Descendant · cites it directly · 2 of its ownK022200 Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 2002 · Recalled
- Descendant · 2 generations on · 1 of its ownK050719 Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005 · Recalled
- Descendant · cites it directly · 1 of its ownK041882 Flowcare SystemPointcare Technologies, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK151133 Pentra XLRHoriba Abx Sas · 2015
- Descendant · 2 generations on · 0 of its ownK072869 Pointcare Now SystemPointcare Technologies, Inc. · 2008 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 2002 · cites it directly2descendants
- K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005 · 2 generations on1descendant
- K041882Flowcare SystemPointcare Technologies, Inc. · 2004 · cites it directly1descendant
- K151133Pentra XLRHoriba Abx Sas · 2015 · 3 generations on0descendants
- K072869Pointcare Now SystemPointcare Technologies, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K885093 | Coulter STKS | Coulter Electronics, Inc. | 1988 | — |
| 0 (this device) | K962988 | Coulter Gen-S System | Coulter Corp. | 1996 | — |
| +1 | K022200 | Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 | Abx Diagnostics | 2002 | 2 |
| +2 | K050719 | Abx Pentra DX 120: Option SPS Evolution | Horiba Abx | 2005 | 1 |
| +1 | K041882 | Flowcare System | Pointcare Technologies, Inc. | 2004 | — |
| +3 | K151133 | Pentra XLR | Horiba Abx Sas | 2015 | — |
| +2 | K072869 | Pointcare Now System | Pointcare Technologies, Inc. | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K885093 | Coulter STKSSummary page 1…864.5850 Device Class: Class I, Exempt 510(k) numbers of Coulter devices to which substantial equivalence is claimed: COULTER® STKS Analyzer with Reticulocyte Analysis, K885093 and K932030 The product is an Automated Differential Cell Counter which like the predicate device COULTER® STKS Analyzer with Re… | 1988 |
| * | K932030 | Coulter STKS with Reticulocyte Analysis CapabilitySummary page 1…ice Class: Class I, Exempt 510(k) numbers of Coulter devices to which substantial equivalence is claimed: COULTER® STKS Analyzer with Reticulocyte Analysis, K885093 and K932030 The product is an Automated Differential Cell Counter which like the predicate device COULTER® STKS Analyzer with Reticulocyte A… | 1993 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 31, 2011 | Not classified | Z-1956-2011 | Software design | 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 transmit as a blank field to the LIS… |
| Apr 18, 2007 | Not classified | Z-0315-2008 | Software design | 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 will accept the entry and no error… |
| Dec 15, 2005 | Not classified | Z-0475-06 | Other | There is a risk of sample misidentification when processing samples in the Manual aspiration mode. |
| Dec 10, 2002 | Not classified | Z-0571-03 | Other | Device design allows for cross contamination issue to occur, possibly affecting assays and results reports. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GKL devicesGKL Counter, Cell, Automated (Particle Counter): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKL
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · GKL
Too few GKL 510(k)s in any year since 2007 to give a median.
Recalls per year · GKL
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKL
1in 2025
MAUDE reports naming product code GKL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 25 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 31 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962988 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962988: Coulter Gen-S System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962988
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026