510(k) · Cleared
Recalled · Class II · 2015Coulter LH 780 Hematology Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · GKZ Counter, Differential Cell
Cleared on Oct 4, 2006 as substantially equivalent to K011342 (Beckman Coulter, Inc., 2001) and 2 other predicates after a 118-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it. It has been recalled 7 times.
- Decided
- Oct 4, 2006
- Review
- 118 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 3 generations to K912494 (1991). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK912494 Sysmex (TM) R-3000 Automated Reticulocyte AnalyzerToa Medical Electronics USA, Inc. · 1991
- 2 generations backK964375 Sysmex SE/Ram-1Sysmex Corp. · 1997
- 1 generation backK992875 Sysmex XE-2100, Automatated Hematology AnalyzerSysmex Corp. · 1999 · Recalled
- This deviceK061616 Coulter LH 780 Hematology AnalyzerBeckman Coulter, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK081930 Unicel DXH 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc. · 2008 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K081930Unicel DXH 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912494 | Sysmex (TM) R-3000 Automated Reticulocyte Analyzer | Toa Medical Electronics USA, Inc. | 1991 | — |
| −2 | K964375 | Sysmex SE/Ram-1 | Sysmex Corp. | 1997 | — |
| −1 | K992875 | Sysmex XE-2100, Automatated Hematology Analyzer | Sysmex Corp. | 1999 | 1 |
| 0 (this device) | K061616 | Coulter LH 780 Hematology Analyzer | Beckman Coulter, Inc. | 2006 | — |
| +1 | K081930 | Unicel DXH 800 Coulter Cellular Analysis System | Beckman Coulter, Inc. | 2008 | 29 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K011342 | Coulter LH 750 Hematology Analyzer, Model 6605632Summary page 1…Number COULTER" LH 780 COULTER ® LH 750 Beckman Coulter, Inc. K011342 Hematology Analyzer Hematology Analyzer COULTER® LH 750… | 2001 |
| * | K030606 | Coulter LH 750 Body Fluids ApplicationSummary page 1…c. K011342 Hematology Analyzer Hematology Analyzer COULTER® LH 750 Beckman Coulter, Inc. K030606 Body Fluids Application (for Body Fluids equivalence only)… | 2003 |
| * | K992875 | Sysmex XE-2100, Automatated Hematology AnalyzerSummary page 1…n (for Body Fluids equivalence only) SysmexTM Automated Sysmex Corporation K992875 Hematology Analyzer XE-2100… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081930 | Unicel DXH 800 Coulter Cellular Analysis System | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 22, 2015 | Class II | Z-2481-2015 | Nonconforming Material/Component | Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette. |
| Jul 22, 2015 | Class II | Z-2480-2015 | Nonconforming Material/Component | Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette. |
| Nov 8, 2013 | Class II | Z-0471-2014 | Under Investigation by firm | Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or… |
| Sep 24, 2013 | Class II | Z-0113-2014 | Component change control | The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and Coulter LH 780 Hematology Analyzer (PN 723585 and A90728). A failure may result in an air or liquid leak at the connection to the Vacuum… |
| Dec 1, 2011 | Not classified | Z-1241-2012 | Software design | The recall was initiated because Beckman Coulter has confirmed that the Auto Stop and Auto Transmit features for Quality Control become disabled after scanning assay values from Coulter 5C and Retic-C Cell Controls assay sheets using the… |
| Jan 31, 2011 | Not classified | Z-1954-2011 | Software design | This recall was initiated because Beckman Coulter identified a problem with some date fields that are transmitted to the Laboratory Information System (LIS). Starting Jan 1, 2011, the date fields will transmit as a blank field to the LIS… |
| Apr 18, 2007 | Not classified | Z-0313-2008 | Software design | Patient Mis-identification can occur: 1)- When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is already in the To Do list. The workstation will accept the entry and no error… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K081930 (Beckman Coulter, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K011342.
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 LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061616 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061616: Coulter LH 780 Hematology Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061616
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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