510(k) · Cleared
ClearedVega Hematology Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abx, Inc. · GKZ Counter, Differential Cell
Cleared on Nov 4, 1996 after a 122-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Nov 4, 1996
- Review
- 122 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK962633 Vega Hematology AnalyzerAbx, Inc. · 1996
- Descendant · cites it directly · 4 of its ownK990311 Vega Retic Automated Hematology AnalyzerAbx Diagnostics · 1999
- Descendant · cites it directly · 3 of its ownK992511 Abx Pentra 60 Hematology AnalyzerAbx Diagnostics · 1999 · Recalled
- Descendant · 2 generations on · 3 of its ownK991839 Abx Pentra 120 Retic Automated Hematology AnalyzerAbx Diagnostics · 1999
- Descendant · cites it directly · 2 of its ownK022200 Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 2002 · Recalled
- Descendant · cites it directly · 1 of its ownK050719 Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K990311Vega Retic Automated Hematology AnalyzerAbx Diagnostics · 1999 · cites it directly4descendants
- K992511Abx Pentra 60 Hematology AnalyzerAbx Diagnostics · 1999 · cites it directly3descendants
- K991839Abx Pentra 120 Retic Automated Hematology AnalyzerAbx Diagnostics · 1999 · 2 generations on3descendants
- K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 2002 · cites it directly2descendants
- K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962633 | Vega Hematology Analyzer | Abx, Inc. | 1996 | — |
| +1 | K990311 | Vega Retic Automated Hematology Analyzer | Abx Diagnostics | 1999 | — |
| +1 | K992511 | Abx Pentra 60 Hematology Analyzer | Abx Diagnostics | 1999 | 1 |
| +2 | K991839 | Abx Pentra 120 Retic Automated Hematology Analyzer | Abx Diagnostics | 1999 | — |
| +1 | K022200 | Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 | Abx Diagnostics | 2002 | 2 |
| +1 | K050719 | Abx Pentra DX 120: Option SPS Evolution | Horiba Abx | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | — | TECHNICON H2 Hematology Analyzer Named without a submission number | |
| * | — | ABBOT CELL-DYN 3500 Hematology Analyzer Named without a submission number | |
| * | — | COULTER STKS Hematology Analyzer Named without a submission number |
What descends from it? (9)
4 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, K990311 (Abx Diagnostics, 1999) has gone furthest, with 4 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 | — |
What is it indicated for?
performing a twenty parameters hematological profile of whole blood specimens.
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/K962633 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962633: Vega Hematology Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962633
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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