510(k) · Cleared

Cleared

Abx Micros 60 Hematology Analyzer

K014203510(k) TraditionalCleared Feb 28, 200269-day reviewClass II21 CFR 864.5200

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

Abx Diagnostics · GKX Instrument, Automated Platelet Counting

Cleared on Feb 28, 2002 after a 69-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Feb 28, 2002
Review: 69 days
Class: Class II
Product code: GKX
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK014203 Abx Micros 60 Hematology AnalyzerAbx Diagnostics · 2002
Descendant · cites it directly · 1 of its ownK030799 Micros 60Abx Diagnostics · 2003
Descendant · 2 generations on · 0 of its ownK141161 Abx Micros ES 60 CT; (Open Tube Model), (Close Tube Model)Horiba Abx Sas · 2014

Most influential descendants

Showing 2 of 2 · See all

K030799Micros 60Abx Diagnostics · 2003 · cites it directly1descendant
K141161Abx Micros ES 60 CT; (Open Tube Model), (Close Tube Model)Horiba Abx Sas · 2014 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K014203	Abx Micros 60 Hematology Analyzer	Abx Diagnostics	2002	—
+1	K030799	Micros 60	Abx Diagnostics	2003	—
+2	K141161	Abx Micros ES 60 CT; (Open Tube Model), (Close Tube Model)	Horiba Abx Sas	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2014	1	0

FIG. 1 — Lineage of K014203, 2002–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	—	BAKER SYSTEM 9110* PLUS Hematology Analyzer Named without a submission number			—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030799	Micros 60	Abx Diagnostics	2003	1

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, K030799 (Abx Diagnostics, 2003) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GKX devices

GKX Instrument, Automated Platelet Counting: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKX

FDA has decided no GKX device since 2007.

Median 510(k) review, days · GKX

Too few GKX 510(k)s in any year since 2007 to give a median.

Recalls per year · GKX

No recall names GKX since 2007.

Adverse event reports per year · GKX

No MAUDE report names GKX since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K014203 · printed Nov 3, 2026

Cite this page

510(k) Report. “K014203: Abx Micros 60 Hematology Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014203

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026