510(k) · Cleared
ClearedSeries 9100 Plus Automated Differential Hematology Analyzers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Serono Diagnostics, Inc. · GKZ Counter, Differential Cell
Cleared on Mar 11, 1996 as substantially equivalent to K911626 (Serono Baker Diagnostics System, 1991) and 1 other predicate after a 223-day review. Its family tree reaches back 1 generation to 1987. 3 later devices descend from it.
- Decided
- Mar 11, 1996
- Review
- 223 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K870603 (1987). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK870603 System 9000 Automated Cell CounterBaker Instructions Corp. · 1987
- This deviceK953598 Series 9100 Plus Automated Differential Hematology AnalyzersSerono Diagnostics, Inc. · 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 · 3 generations on · 0 of its ownK151133 Pentra XLRHoriba Abx Sas · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870603 | System 9000 Automated Cell Counter | Baker Instructions Corp. | 1987 | — |
| 0 (this device) | K953598 | Series 9100 Plus Automated Differential Hematology Analyzers | Serono Diagnostics, Inc. | 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 |
| +3 | K151133 | Pentra XLR | Horiba Abx Sas | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 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 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? (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 |
|---|---|---|---|
| * | K911626 | System 9000, Interpretive Diff Cell CounterSummary page 3…ential hematology analyzers in the Series 9100+ PLUS are substantially equivalent to Serono Baker Diagnostics, Inc.'s System 9000+ Interpretive Diff Model Cell Counters (K911626/B), and the non-differential hematology analyzer in the Series 9100+ PLUS is substantially equivalent to Serono Baker Diagnostics… | 1991 |
| * | K870603 | System 9000 Automated Cell CounterSummary page 3…and the non-differential hematology analyzer in the Series 9100+ PLUS is substantially equivalent to Serono Baker Diagnostics, Inc.’s System 9000 Automated Cell Counter (K870603). (For convenience, these two predicate devices will hereafter be referred to together as the “predicate System 9000+/System 9000… | 1987 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022200 | Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 | 2002 | 2 |
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?
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 | — |
What is it indicated for?
Each of the four models within the Series 9100+ PLUS (i.e., Model 9120, Model 9118, Model 9110, and Model 9100 Rx) is intended for use as a fully automated hematology cell counter for the in vitro diagnostic testing of whole blood specimens. The Series 9100+ PLUS also is intended to flag or identify specimens containing abnormal blood cells.
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/K953598 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953598: Series 9100 Plus Automated Differential Hematology Analyzers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953598
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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