510(k) · Cleared
ClearedSysmex Immature Reticulocyte Fraction (Irf) Parameter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sysmex Corp. · GKZ Counter, Differential Cell
Cleared on Aug 26, 1997 after a 106-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Aug 26, 1997
- Review
- 106 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK971736 Sysmex Immature Reticulocyte Fraction (Irf) ParameterSysmex Corp. · 1997
- Descendant · cites it directly · 3 of its ownK991839 Abx Pentra 120 Retic Automated Hematology AnalyzerAbx Diagnostics · 1999
- Descendant · 2 generations on · 2 of its ownK022200 Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 2002 · Recalled
- Descendant · 2 generations on · 1 of its ownK050719 Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK151133 Pentra XLRHoriba Abx Sas · 2015
- Descendant · cites it directly · 0 of its ownK993356 Coulter Hematology Analyzers with Irf & MRV AnalysesCoulter Corp. · 2000
Most influential descendants
Showing 5 of 5 · See all- K991839Abx Pentra 120 Retic Automated Hematology AnalyzerAbx Diagnostics · 1999 · cites it directly3descendants
- K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 2002 · 2 generations on2descendants
- K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005 · 2 generations on1descendant
- K151133Pentra XLRHoriba Abx Sas · 2015 · 2 generations on0descendants
- K993356Coulter Hematology Analyzers with Irf & MRV AnalysesCoulter Corp. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971736 | Sysmex Immature Reticulocyte Fraction (Irf) Parameter | Sysmex Corp. | 1997 | — |
| +1 | K991839 | Abx Pentra 120 Retic Automated Hematology Analyzer | Abx Diagnostics | 1999 | — |
| +2 | K022200 | Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 | Abx Diagnostics | 2002 | 2 |
| +2 | K050719 | Abx Pentra DX 120: Option SPS Evolution | Horiba Abx | 2005 | 1 |
| +2 | K151133 | Pentra XLR | Horiba Abx Sas | 2015 | — |
| +1 | K993356 | Coulter Hematology Analyzers with Irf & MRV Analyses | Coulter Corp. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2015 | 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? (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 | Decided |
|---|---|---|---|
| * | — | reticulocyte count Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K991839 (Abx Diagnostics, 1999) has gone furthest, with 3 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 IRF parameter of the R-Series analyzers is intended for in-vitro use in clinical laboratories. Its clinical use is to monitor bone marrow suppression and recovery in terms of erythropoiesis in situations of previous cancer chemotherapeutic bone marrow suppression and bone marrow transplantation. Qualified laboratory personnel are responsible for review of all abnormal results.
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/K971736 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971736: Sysmex Immature Reticulocyte Fraction (Irf) Parameter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971736
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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