510(k) · Cleared
Recalled · 2004Pentra 80
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abx Diagnostics · GKZ Counter, Differential Cell
Cleared on Jan 3, 2003 as substantially equivalent to K003677 (Abx Diagnostics, 2000) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jan 3, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K872166 (1987). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK872166 Facscan Flow Cytometer - Reticcount Reti. Enu. KitBd Becton Dickinson Vacutainer Systems Preanalytic · 1987
- 1 generation backK961439 Abbott Cell-Dyn 4000 SystemAbbott Diagnostics · 1996 · Recalled
- This deviceK024002 Pentra 80Abx Diagnostics · 2003
- Descendant · cites it directly · 0 of its ownK151133 Pentra XLRHoriba Abx Sas · 2015
Most influential descendants
Showing 1 of 1 · See all- K151133Pentra XLRHoriba Abx Sas · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872166 | Facscan Flow Cytometer - Reticcount Reti. Enu. Kit | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987 | — |
| −1 | K961439 | Abbott Cell-Dyn 4000 System | Abbott Diagnostics | 1996 | 7 |
| 0 (this device) | K024002 | Pentra 80 | Abx Diagnostics | 2003 | — |
| +1 | K151133 | Pentra XLR | Horiba Abx Sas | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K003677 | Abx Pentra 60C+ Hematology AnalyzerSummary page 2…6- 1 Substantial Equivalence: The ABX PENTRA 80 based on the same fundamental technology as the predicate device ABX PENTRA 60C+ cleared to market under K003677. The use of a second predicate device to show its clinical capability compatibility was used ABBOTT CD 4000 (K961439). Descrip… | 2000 |
| * | K961439 | Abbott Cell-Dyn 4000 SystemSummary page 2…cate device ABX PENTRA 60C+ cleared to market under K003677. The use of a second predicate device to show its clinical capability compatibility was used ABBOTT CD 4000 (K961439). Description: The PENTRA 80 Hematology analyzer is a benchtop, clinical laboratory instrument which analyzes in-vitro samples… | 1996 |
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 |
|---|---|---|---|
| K151133 | Pentra XLR | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 13, 2004 | Not classified | Z-0002-05 | Other | Device can generate overestimated platelet results. |
| Aug 13, 2004 | Not classified | Z-0003-05 | Other | Device can generate overestimated platelet results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K151133 (Horiba Abx Sas, 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K003677.
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 ABX PENTRA 80 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.
The ABX PENTRA 80 is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024002 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024002: Pentra 80.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024002
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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