510(k) · Cleared
ClearedSystem 9000, Interpretive Diff Cell Counter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Serono Baker Diagnostics System · GKZ Counter, Differential Cell
Cleared on Sep 13, 1991 after a 155-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Sep 13, 1991
- Review
- 155 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK911626 System 9000, Interpretive Diff Cell CounterSerono Baker Diagnostics System · 1991
- Descendant · cites it directly · 3 of its ownK953598 Series 9100 Plus Automated Differential Hematology AnalyzersSerono Diagnostics, Inc. · 1996
- Descendant · 2 generations on · 2 of its ownK022200 Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 2002 · Recalled
- Descendant · 3 generations on · 1 of its ownK050719 Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005 · Recalled
- Descendant · 4 generations on · 0 of its ownK151133 Pentra XLRHoriba Abx Sas · 2015
- Descendant · cites it directly · 0 of its ownK960072 Spirit Hematology System Model LE, CP, & AXBiochem Immunosystems (U.S.), Inc. · 1997
Most influential descendants
Showing 5 of 5 · See all- K953598Series 9100 Plus Automated Differential Hematology AnalyzersSerono Diagnostics, Inc. · 1996 · cites it directly3descendants
- K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 2002 · 2 generations on2descendants
- K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005 · 3 generations on1descendant
- K151133Pentra XLRHoriba Abx Sas · 2015 · 4 generations on0descendants
- K960072Spirit Hematology System Model LE, CP, & AXBiochem Immunosystems (U.S.), Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911626 | System 9000, Interpretive Diff Cell Counter | Serono Baker Diagnostics System | 1991 | — |
| +1 | K953598 | Series 9100 Plus Automated Differential Hematology Analyzers | Serono Diagnostics, Inc. | 1996 | — |
| +2 | K022200 | Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 | Abx Diagnostics | 2002 | 2 |
| +3 | K050719 | Abx Pentra DX 120: Option SPS Evolution | Horiba Abx | 2005 | 1 |
| +4 | K151133 | Pentra XLR | Horiba Abx Sas | 2015 | — |
| +1 | K960072 | Spirit Hematology System Model LE, CP, & AX | Biochem Immunosystems (U.S.), Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GKZ device
- #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K953598 (Serono Diagnostics, Inc., 1996) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, 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 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
https://510kreport.com/device/K911626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911626: System 9000, Interpretive Diff Cell Counter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911626
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026