510(k) Report

510(k) · Cleared

Cleared

Coulter AC.T Series Analyzer

K964988510(k) TraditionalCleared Mar 6, 199783-day reviewClass II21 CFR 864.5220

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Coulter Corp. · GKZ Counter, Differential Cell

Cleared on Mar 6, 1997 as substantially equivalent to K823355 (Coulter Electronics, Inc., 1982) after an 83-day review. Its family tree reaches back 1 generation to 1982. 6 later devices descend from it.

Decided
Mar 6, 1997
Review
83 days
Class
Class II
Product code
GKZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K823355 (1982). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared1999: 1 descendant cleared2010: 1 descendant cleared2007: 1 descendant cleared2015: 1 descendant clearedK823355 · Coulter-Counter #S Plus IV & Lyse S +D · Coulter Electronics, Inc. · 198219801990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 1 descendant K823355 · Coulter-Counter #S Plus IV & Lyse S +D · Coulter Electronics, Inc. · 19820
  1. Root · 1 generation backK823355 Coulter-Counter #S Plus IV & Lyse S +DCoulter Electronics, Inc. · 1982
  2. This deviceK964988 Coulter AC.T Series AnalyzerCoulter Corp. · 1997
  3. Descendant · cites it directly · 4 of its ownK973634 Coulter AC.T Diff AnalyzerCoulter Corp. · 1997
  4. Descendant · 2 generations on · 3 of its ownK990352 Coulter AC T Diff 2 AnalyzerCoulter Corp. · 1999 · Recalled
  5. Descendant · 3 generations on · 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
  6. Descendant · 4 generations on · 0 of its ownK143348 BC-3600 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd. · 2015
  7. Descendant · 3 generations on · 0 of its ownK063407 BC-3200 Auto Hematology AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1997: 21999: 12007: 12010: 12015: 1
1997high 2 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 6 · See all
  • K973634Coulter AC.T Diff AnalyzerCoulter Corp. · 1997 · cites it directly4descendants
  • K990352Coulter AC T Diff 2 AnalyzerCoulter Corp. · 1999 · 2 generations on3descendants
  • 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 · 3 generations on1descendant
  • K143348BC-3600 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd. · 2015 · 4 generations on0descendants
  • K063407BC-3200 Auto Hematology AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K823355Coulter-Counter #S Plus IV & Lyse S +DCoulter Electronics, Inc.1982—
0 (this device)K964988Coulter AC.T Series AnalyzerCoulter Corp.1997—
+1K973634Coulter AC.T Diff AnalyzerCoulter Corp.1997—
+2K990352Coulter AC T Diff 2 AnalyzerCoulter Corp.19991
+3K093394BC-3200 Auto Hematology Analyzer,M-30D Diluent, M-30R Rinse, M-30CFL Lyse…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2010—
+4K143348BC-3600 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd.2015—
+3K063407BC-3200 Auto Hematology AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199910
200710
201010
201510
FIG. 1 — Lineage of K964988, 1982–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K823355Coulter-Counter #S Plus IV & Lyse S +D
Summary page 1
….5200 and 864.5220 Device Class: Class 11 510(k) numbers of Coulter devices to which substantial equivalence is claimed: COULTER® COUNTER® S-PLUS IV and LYSE S PLUS D, K823355. The product is a hematology Automated Cell Counter and Automated Differential Cell Counter which like the predicate device, COU…
Coulter Electronics, Inc.1982—

Also cleared against K823355: 3 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K973634Coulter AC.T Diff AnalyzerCoulter Corp.19974
K971469Coulter Act Tron Cell ControlCoulter Corp.19970

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?

  • Its one ancestor has no recall.
  • Of its descendants, K973634 (Coulter Corp., 1997) has gone furthest, with 4 descendants of its own.
  • 3 other devices also cite its predicate K823355.

How does its category compare?

All GKZ devices

GKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKZ

4in 2025

2007: 62008: 62009: 62010: 42011: 32012: 32013: 12014: 32015: 32016: 32017: 42018: 32019: 52020: 12022: 32023: 42024: 32025: 42026 (partial year): 4
2007high 6 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKZ

108in 2025

2007: 117 days median2008: 99 days median2009: 147 days median2010: 290 days median2011: 315 days median2012: 408 days median2014: 165 days median2015: 273 days median2016: 198 days median2017: 280 days median2018: 270 days median2019: 210 days median2022: 638 days median2023: 329 days median2024: 157 days median2025: 108 days median2026 (partial year): 254 days median
2007high 638 (2022) · low 99 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GKZ

1in 2025

2007: 372008: 52009: 132010: 272011: 282012: 72013: 62015: 32016: 32017: 32018: 2, 2 Class I2019: 22020: 12022: 42023: 12025: 1
2007high 37 (2007) · low 0 (2014)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · GKZ

77in 2025

2007: 2682008: 9252009: 5592010: 8962011: 2,9052012: 2,9592013: 3,0702014: 3,1122015: 1,9722016: 3,3382017: 2292018: 4972019: 9082020: 3422021: 3912022: 1982023: 1552024: 1152025: 77
2007high 3,338 (2016) · low 77 (2025)2025

MAUDE reports naming product code GKZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007611737268
20086995925
2009614713559
2010429027896
20113315282,905
2012340872,959
20131—63,070
2014316503,112
2015327331,972
2016319833,338
201742803229
201832702 (2)497
201952102908
20201—1342
20210—0391
202236384198
202343291155
202431570115
20254108177
202642540—

What is it indicated for?

The COULTER® AC-T Series Analyzers are quantitative, automated hematology analyzers. The AC-T 10 Series is also a leukocyte differential counter. Both instruments are 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.

Also cleared against K823355

3 other devices cite the same predicate.

  • K990352Coulter AC T Diff 2 AnalyzerCoulter Corp. · 19991 recall
  • K973634Coulter AC.T Diff AnalyzerCoulter Corp. · 1997
  • K955715Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification)Abbott Laboratories · 19961 recall

More from Coulter Corp.

51 FDA decisions under this applicant name. See the company

  • K993356Coulter Hematology Analyzers with Irf & MRV AnalysesCoulter Corp. · 2000
  • K991070Coulter Z2 AnalyzerCoulter Corp. · 1999
  • K990327Reticone System for Epics XL Flow Cytometry SystemsCoulter Corp. · 1999
  • K990172Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…Coulter Corp. · 19991 Class I recall
  • K990352Coulter AC T Diff 2 AnalyzerCoulter Corp. · 19991 recall

Recent decisions in GKZ

The GKZ category page

  • K260781Yumizen H550Horiba Abx Sas · 2026
  • K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc. · 2026
  • K243348Athelas HomeAthelas, Inc. · 2026
  • K251249Tru Hematology TestTruvian Sciences, Inc. · 2026
  • K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc. · 2025

https://510kreport.com/device/K964988 · printed Nov 5, 2026

Cite this page

510(k) Report. “K964988: Coulter AC.T Series Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964988

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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