510(k) · Cleared
Recalled · 2004Coulter AC T Diff 2 Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coulter Corp. · GKZ Counter, Differential Cell
Cleared on Apr 1, 1999 as substantially equivalent to K973634 (Coulter Corp., 1997) and 1 other predicate after a 55-day review. Its family tree reaches back 3 generations to 1982. 3 later devices descend from it. It has been recalled once.
- Decided
- Apr 1, 1999
- Review
- 55 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K823355 (1982). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK823355 Coulter-Counter #S Plus IV & Lyse S +DCoulter Electronics, Inc. · 1982
- 2 generations backK964988 Coulter AC.T Series AnalyzerCoulter Corp. · 1997
- 1 generation backK973634 Coulter AC.T Diff AnalyzerCoulter Corp. · 1997
- This deviceK990352 Coulter AC T Diff 2 AnalyzerCoulter Corp. · 1999
- Descendant · cites it directly · 1 of its ownK093394 BC-3200 Auto Hematology Analyzer,M-30D Diluent, M-30R Rinse, M-30CFL…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK143348 BC-3600 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK063407 BC-3200 Auto Hematology AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
Most influential descendants
Showing 3 of 3 · See all- K093394BC-3200 Auto Hematology Analyzer,M-30D Diluent, M-30R Rinse, M-30CFL Lyse, M-30E-Z…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010 · cites it directly1descendant
- K143348BC-3600 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on0descendants
- K063407BC-3200 Auto Hematology AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K823355 | Coulter-Counter #S Plus IV & Lyse S +D | Coulter Electronics, Inc. | 1982 | — |
| −2 | K964988 | Coulter AC.T Series Analyzer | Coulter Corp. | 1997 | — |
| −1 | K973634 | Coulter AC.T Diff Analyzer | Coulter Corp. | 1997 | — |
| 0 (this device) | K990352 | Coulter AC T Diff 2 Analyzer | Coulter Corp. | 1999 | — |
| +1 | K093394 | BC-3200 Auto Hematology Analyzer,M-30D Diluent, M-30R Rinse, M-30CFL Lyse… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| +2 | K143348 | BC-3600 Auto Hematology Analyzer | Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +1 | K063407 | BC-3200 Auto Hematology Analyzer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K973634 | Coulter AC.T Diff AnalyzerSummary page 1…al cell counter is a device used to identify and classify one or more of the formed elements of blood. (CFR 864.5220) Predicate Device(s) COULTER® Ac-T diff™ Analyzer (K973634) COULTER® COUNTER® S-PLUS IV and LYSE S PLUS D (K823355) Description The COULTER® Ac-T diff 2™ Analyzer is a quantitative, auto… | 1997 |
| * | K823355 | Coulter-Counter #S Plus IV & Lyse S +DSummary page 1…y one or more of the formed elements of blood. (CFR 864.5220) Predicate Device(s) COULTER® Ac-T diff™ Analyzer (K973634) COULTER® COUNTER® S-PLUS IV and LYSE S PLUS D (K823355) Description The COULTER® Ac-T diff 2™ Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cou… | 1982 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 3, 2004 | Not classified | Z-0339-05 | Other | Erroneous results issue when MONOJECT blood collection tubes are used during analysis after tubes are uncapped and recapped then analysed in the closed vial mode. Results are lower than if cap had not been removed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K093394 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2010) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The COULTER® AC-T diff 2™ analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.
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/K990352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990352: Coulter AC T Diff 2 Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990352
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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