510(k) · Cleared
ClearedMicros 60
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 Apr 8, 2003 as substantially equivalent to K014203 (Abx Diagnostics, 2002) and 1 other predicate after a 26-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Apr 8, 2003
- Review
- 26 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962633 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK962633 Vega Hematology AnalyzerAbx, Inc. · 1996
- 1 generation backK992511 Abx Pentra 60 Hematology AnalyzerAbx Diagnostics · 1999 · Recalled
- This deviceK030799 Micros 60Abx Diagnostics · 2003
- Descendant · cites it directly · 0 of its ownK141161 Abx Micros ES 60 CT; (Open Tube Model), (Close Tube Model)Horiba Abx Sas · 2014
Most influential descendants
Showing 1 of 1 · See all- K141161Abx Micros ES 60 CT; (Open Tube Model), (Close Tube Model)Horiba Abx Sas · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962633 | Vega Hematology Analyzer | Abx, Inc. | 1996 | — |
| −1 | K992511 | Abx Pentra 60 Hematology Analyzer | Abx Diagnostics | 1999 | 1 |
| 0 (this device) | K030799 | Micros 60 | Abx Diagnostics | 2003 | — |
| +1 | K141161 | Abx Micros ES 60 CT; (Open Tube Model), (Close Tube Model) | Horiba Abx Sas | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K014203 | Abx Micros 60 Hematology AnalyzerSummary page 2…Section 6- 1 Substantial Equivalence: The ABX MICROS 60 is based on the same fundamental technology as the predlicate devices cleared to market under K014203. The use of a predicate device to show the clinical capability was ABBOTT CD 4000 (K961439). Description: The ABX MICROS 60 de… | 2002 |
| * | K992511 | Abx Pentra 60 Hematology AnalyzerSummary page 2…Determination of substantial equivalence : The ABX MICROS 60 the released software version 1.6 is substantially equivalent to the already cleared device MICROS 60 v1.4 (K992511) with respect to the indications for use, the hematological parameters for complete blood count and 3 part differential leucocyte… | 1999 |
| † | K961439 | Abbott Cell-Dyn 4000 System | 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 |
|---|---|---|---|
| K141161 | Abx Micros ES 60 CT; (Open Tube Model), (Close Tube Model) | 2014 | 0 |
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K141161 (Horiba Abx Sas, 2014) has gone furthest, with 0 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?
The ABX MICROS 60 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens or blood cell concentrates. It operates in complete blood count (CBC) mode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030799 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030799: Micros 60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030799
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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