510(k) · Cleared
ClearedSysmex (TM) R-3000 Automated Reticulocyte Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toa Medical Electronics USA, Inc. · GKL Counter, Cell, Automated (Particle Counter)
Cleared on Sep 10, 1991 after a 97-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 13 later devices descend from it.
- Decided
- Sep 10, 1991
- Review
- 97 days
- Class
- Class II
- Product code
- GKL
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 3 citing it directly.
- This deviceK912494 Sysmex (TM) R-3000 Automated Reticulocyte AnalyzerToa Medical Electronics USA, Inc. · 1991
- Descendant · cites it directly · 9 of its ownK964375 Sysmex SE/Ram-1Sysmex Corp. · 1997
- Descendant · 2 generations on · 7 of its ownK992875 Sysmex XE-2100, Automatated Hematology AnalyzerSysmex Corp. · 1999 · Recalled
- Descendant · cites it directly · 4 of its ownK990311 Vega Retic Automated Hematology AnalyzerAbx Diagnostics · 1999
- Descendant · 2 generations on · 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
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K964375Sysmex SE/Ram-1Sysmex Corp. · 1997 · cites it directly9descendants
- K992875Sysmex XE-2100, Automatated Hematology AnalyzerSysmex Corp. · 1999 · 2 generations on7descendants
- K990311Vega Retic Automated Hematology AnalyzerAbx Diagnostics · 1999 · cites it directly4descendants
- K991839Abx Pentra 120 Retic Automated Hematology AnalyzerAbx Diagnostics · 1999 · 2 generations on3descendants
- K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 2002 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912494 | Sysmex (TM) R-3000 Automated Reticulocyte Analyzer | Toa Medical Electronics USA, Inc. | 1991 | — |
| +1 | K964375 | Sysmex SE/Ram-1 | Sysmex Corp. | 1997 | — |
| +2 | K992875 | Sysmex XE-2100, Automatated Hematology Analyzer | Sysmex Corp. | 1999 | 1 |
| +1 | K990311 | Vega Retic Automated Hematology Analyzer | Abx Diagnostics | 1999 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (13)
See all 133 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, K964375 (Sysmex Corp., 1997) has gone furthest, with 9 descendants of its own.
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 | — |
https://510kreport.com/device/K912494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912494: Sysmex (TM) R-3000 Automated Reticulocyte Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912494
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026