510(k) · Cleared
ClearedCoulter Hematology Analyzers with Irf & MRV Analyses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coulter Corp. · GKZ Counter, Differential Cell
Cleared on Apr 20, 2000 as substantially equivalent to K971736 (Sysmex Corp., 1997) and 2 other predicates after a 197-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Apr 20, 2000
- Review
- 197 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K885093 (1988). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K885093 | Coulter STKS | Coulter Electronics, Inc. | 1988 | — |
| −1 | K962988 | Coulter Gen-S System | Coulter Corp. | 1996 | 4 |
| 0 (this device) | K993356 | Coulter Hematology Analyzers with Irf & MRV Analyses | Coulter Corp. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1997 | 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 |
|---|---|---|---|
| * | K971736 | Sysmex Immature Reticulocyte Fraction (Irf) ParameterSummary page 1…to identify and classify one or more of the formed elements of blood. (CFR 864.5220) .The Classification Number is 81GKZ. Predicate Device(s) Sysmex™ w/IRF Parameter (K971736/S1), COULTER® GEN-S™ System (K962988), COULTER® New Methylene Blue Prep Retic MAXM/AL Analyzers (K925344) Description The Immat… | 1997 |
| * | K962988 | Coulter Gen-S SystemSummary page 1…of the formed elements of blood. (CFR 864.5220) .The Classification Number is 81GKZ. Predicate Device(s) Sysmex™ w/IRF Parameter (K971736/S1), COULTER® GEN-S™ System (K962988), COULTER® New Methylene Blue Prep Retic MAXM/AL Analyzers (K925344) Description The Immature Reticulocyte Fraction expresses t… | 1996 |
| * | K925344 | Coulter New Meth Blue Preprep Retic/Maxm W/AutoloaSummary page 1…Number is 81GKZ. Predicate Device(s) Sysmex™ w/IRF Parameter (K971736/S1), COULTER® GEN-S™ System (K962988), COULTER® New Methylene Blue Prep Retic MAXM/AL Analyzers (K925344) Description The Immature Reticulocyte Fraction expresses the number of early reticulocytes as a proportion of the total reticu… | 1993 |
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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K971736.
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 COULTER GEN-S System with IRF and MRV Parameters is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER GEN-S System also provides automated Reticulocyte analysis.
An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood.
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/K993356 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993356: Coulter Hematology Analyzers with Irf & MRV Analyses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993356
Report an extraction error
Are you the manufacturer?
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