510(k) · Cleared
ClearedReticone System for Epics XL Flow Cytometry Systems
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 26, 1999 as substantially equivalent to K872166 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1987) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Apr 26, 1999
- Review
- 83 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K872166 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK872166 Facscan Flow Cytometer - Reticcount Reti. Enu. KitBd Becton Dickinson Vacutainer Systems Preanalytic · 1987
- This deviceK990327 Reticone System for Epics XL Flow Cytometry SystemsCoulter Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872166 | Facscan Flow Cytometer - Reticcount Reti. Enu. Kit | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987 | — |
| 0 (this device) | K990327 | Reticone System for Epics XL Flow Cytometry Systems | Coulter Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 |
|---|---|---|---|
| * | K872166 | Facscan Flow Cytometer - Reticcount Reti. Enu. KitSummary page 1…and allows identification and enumeration of reticulocyte percentage and absolute count. Substantial Equivalence: Product Differences: 510(k) Premarket Notification: K872166 Retic-COUNT™ (Thiazole Orange*) Reagent 510(k) Premarket Notification: K880636 Retic-COUNT™ Reticulocyte Enumeration Software T… | 1987 |
| * | K880636 | Reticcount SoftwareSummary page 1…te count. Substantial Equivalence: Product Differences: 510(k) Premarket Notification: K872166 Retic-COUNT™ (Thiazole Orange*) Reagent 510(k) Premarket Notification: K880636 Retic-COUNT™ Reticulocyte Enumeration Software The reticONE™ SYSTEM and Retic-COUNT™ are essentially identical with respect to f… | 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?
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K872166.
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 reticONE™ SYSTEM for EPICS® XL™ Flow Cytometry Systems combines a reagent Kit consisting of a Coriphosphine-O dye and a Biological Calibrator, and software for automated analysis of reticulocytes in whole blood using EPICS® XL™ Flow Cytometry Systems with SYSTEM II™ Software. The system is intended “For In Vitro Diagnostic Use” and allows identification and enumeration of reticulocyte percentage and absolute count. The reticulocyte count is…
Read the full statement (235 words)
The reticONE™ SYSTEM for EPICS® XL™ Flow Cytometry Systems combines a reagent Kit consisting of a Coriphosphine-O dye and a Biological Calibrator, and software for automated analysis of reticulocytes in whole blood using EPICS® XL™ Flow Cytometry Systems with SYSTEM II™ Software. The system is intended “For In Vitro Diagnostic Use” and allows identification and enumeration of reticulocyte percentage and absolute count.
The reticulocyte count is diagnostically useful in discriminating between normal and abnormal erythropoiesis. It can be useful in the diagnosis or detection of anemias, internal hemorrhaging, hemoglobinopathies and certain nutritional or vitamin deficiencies. Decreased or defective red cell production may result in a lower reticulocyte count such as in aplastic anemias. Elevated reticulocyte counts may be observed in clinical conditions where red cell destruction is increased (for example, hemolytic anemias and hypersplenism) or where there is increased red cell production (for example, erythropoietin drug therapy and a response to treated anemia).
Since the kidneys are a primary source of erythropoietin (a hormone that regulates erythroid development), the reticulocyte count is also affected in individuals with renal disease. In cases of renal atrophy, the reticulocyte count will be decreased. In cases of malignancy or hypersplenism, the reticulocyte count will be elevated.
Reticulocyte counts are also used as an indicator of bone marrow recovery following intensive cytotoxic chemotherapy or a bone marrow transplantation. Increased reticulocyte counts in these patients are indicative of bone marrow regeneration.
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/K990327 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990327: Reticone System for Epics XL Flow Cytometry Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990327
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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