510(k) · Cleared
ClearedCoulter-Counter #S Plus IV & Lyse S +D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coulter Electronics, Inc. · GKZ Counter, Differential Cell
Cleared on Dec 28, 1982 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Dec 28, 1982
- Review
- 49 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 4 citing it directly.
- This deviceK823355 Coulter-Counter #S Plus IV & Lyse S +DCoulter Electronics, Inc. · 1982
- Descendant · cites it directly · 6 of its ownK964988 Coulter AC.T Series AnalyzerCoulter Corp. · 1997
- Descendant · cites it directly · 4 of its ownK973634 Coulter AC.T Diff AnalyzerCoulter Corp. · 1997
- Descendant · cites it directly · 3 of its ownK990352 Coulter AC T Diff 2 AnalyzerCoulter Corp. · 1999 · Recalled
- Descendant · cites it directly · 3 of its ownK955715 Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer…Abbott Laboratories · 1996 · Recalled
- Descendant · 2 generations on · 2 of its ownK972354 Abbott Cell-Dyn 3200 SystemAbbott Laboratories · 1997 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K964988Coulter AC.T Series AnalyzerCoulter Corp. · 1997 · cites it directly6descendants
- K973634Coulter AC.T Diff AnalyzerCoulter Corp. · 1997 · cites it directly4descendants
- K990352Coulter AC T Diff 2 AnalyzerCoulter Corp. · 1999 · cites it directly3descendants
- K955715Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification)Abbott Laboratories · 1996 · cites it directly3descendants
- K972354Abbott Cell-Dyn 3200 SystemAbbott Laboratories · 1997 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K823355 | Coulter-Counter #S Plus IV & Lyse S +D | Coulter Electronics, Inc. | 1982 | — |
| +1 | K964988 | Coulter AC.T Series Analyzer | Coulter Corp. | 1997 | — |
| +1 | K973634 | Coulter AC.T Diff Analyzer | Coulter Corp. | 1997 | — |
| +1 | K990352 | Coulter AC T Diff 2 Analyzer | Coulter Corp. | 1999 | 1 |
| +1 | K955715 | Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification) | Abbott Laboratories | 1996 | 1 |
| +2 | K972354 | Abbott Cell-Dyn 3200 System | Abbott Laboratories | 1997 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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? (11)
See all 114 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, K964988 (Coulter Corp., 1997) has gone furthest, with 6 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/K823355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K823355: Coulter-Counter #S Plus IV & Lyse S +D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K823355
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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