510(k) · Cleared
ClearedCoulter Z2 Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coulter Corp. · GKL Counter, Cell, Automated (Particle Counter)
Cleared on May 11, 1999 as substantially equivalent to K952308 (Coulter Corp., 1995) and 1 other predicate after a 41-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- May 11, 1999
- Review
- 41 days
- Class
- Class II
- Product code
- GKL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K885093 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK885093 Coulter STKSCoulter Electronics, Inc. · 1988
- This deviceK991070 Coulter Z2 AnalyzerCoulter Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K885093 | Coulter STKS | Coulter Electronics, Inc. | 1988 | — |
| 0 (this device) | K991070 | Coulter Z2 Analyzer | Coulter Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 GKL? 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
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 |
|---|---|---|---|
| * | K952308 | Coulter Z 1Summary page 2…alent to the COULTER® STKS analyzer that was cleared by 510(k) K885093 cleared on Dec. 28, 1988. The COULTER Z2 is the same device as the COULTER® Z1, cleared by 510(k) K952308 on October 6, 1995 except for the measurement of two additional parameters, Mean Cell Volume (MCV) and Mean Platelet Volume (MPV)… | 1995 |
| * | K885093 | Coulter STKSSummary page 2…ge 2 === 5.0 Description COULTER Z2 has the same technological characteristics and is substantially equivalent to the COULTER® STKS analyzer that was cleared by 510(k) K885093 cleared on Dec. 28, 1988. The COULTER Z2 is the same device as the COULTER® Z1, cleared by 510(k) K952308 on October 6, 1995 exc… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All GKL devicesGKL Counter, Cell, Automated (Particle Counter): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKL
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · GKL
Too few GKL 510(k)s in any year since 2007 to give a median.
Recalls per year · GKL
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKL
1in 2025
MAUDE reports naming product code GKL, 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 | 1 | — | 1 | 25 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 31 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The COULTER® Z2 instrument may be used for in vitro diagnostic use to determine the human erythrocyte concentration (Red Cell Count or RBC), leukocyte concentration (White Cell Count or WBC) and thrombocyte concentration (Platelet Count or Plt). In addition, the COULTER Z2 also provides the mean erythrocyte volume (Mean Cell Volume or MCV) and the mean thrombocyte volume (Mean Platelet Volume or MPV).
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/K991070 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991070: Coulter Z2 Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991070
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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