510(k) · Cleared
ClearedSysmex SE/Ram-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sysmex Corp. · GKL Counter, Cell, Automated (Particle Counter)
Cleared on Mar 13, 1997 as substantially equivalent to K936023 (Toa Medical Electronics USA, Inc., 1994) and 1 other predicate after a 132-day review. Its family tree reaches back 1 generation to 1991. 9 later devices descend from it.
- Decided
- Mar 13, 1997
- Review
- 132 days
- Class
- Class II
- Product code
- GKL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912494 (1991). 2 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK912494 Sysmex (TM) R-3000 Automated Reticulocyte AnalyzerToa Medical Electronics USA, Inc. · 1991
- This deviceK964375 Sysmex SE/Ram-1Sysmex Corp. · 1997
- Descendant · cites it directly · 7 of its ownK992875 Sysmex XE-2100, Automatated Hematology AnalyzerSysmex Corp. · 1999 · Recalled
- Descendant · 2 generations on · 1 of its ownK061616 Coulter LH 780 Hematology AnalyzerBeckman Coulter, Inc. · 2006 · 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 ownK160429 BC-5390 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK151133 Pentra XLRHoriba Abx Sas · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K992875Sysmex XE-2100, Automatated Hematology AnalyzerSysmex Corp. · 1999 · cites it directly7descendants
- K061616Coulter LH 780 Hematology AnalyzerBeckman Coulter, Inc. · 2006 · 2 generations on1descendant
- K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005 · 2 generations on1descendant
- K160429BC-5390 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd. · 2016 · 2 generations on0descendants
- K151133Pentra XLRHoriba Abx Sas · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912494 | Sysmex (TM) R-3000 Automated Reticulocyte Analyzer | Toa Medical Electronics USA, Inc. | 1991 | — |
| 0 (this device) | K964375 | Sysmex SE/Ram-1 | Sysmex Corp. | 1997 | — |
| +1 | K992875 | Sysmex XE-2100, Automatated Hematology Analyzer | Sysmex Corp. | 1999 | 1 |
| +2 | K061616 | Coulter LH 780 Hematology Analyzer | Beckman Coulter, Inc. | 2006 | 7 |
| +2 | K050719 | Abx Pentra DX 120: Option SPS Evolution | Horiba Abx | 2005 | 1 |
| +2 | K160429 | BC-5390 Auto Hematology Analyzer | Mindray Bio-Medical Electronics Co., Ltd. | 2016 | — |
| +3 | K151133 | Pentra XLR | Horiba Abx Sas | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K936023 | Sysmex SE-9000 Automated Hematology AnalyzerSummary page 1…mber 10, 1996 MAR | 3 1997 Sysmex™ SE/RAM-1, Trade name and Common name The Sysmex™ SE/RAM-1 is substantially equivalent to the Sysmex™ SE-9000 (Premarket Notification K936023) and the R-3000 (Premarket Notification K912494). The Sysmex™ SE/RAM-1 is classified as a Class II device. Intended Use The SE/R… | 1994 |
| * | K912494 | Sysmex (TM) R-3000 Automated Reticulocyte AnalyzerSummary page 1…rade name and Common name The Sysmex™ SE/RAM-1 is substantially equivalent to the Sysmex™ SE-9000 (Premarket Notification K936023) and the R-3000 (Premarket Notification K912494). The Sysmex™ SE/RAM-1 is classified as a Class II device. Intended Use The SE/RAM-1 is an In Vitro device for whole blood cell… | 1991 |
What descends from it? (9)
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K992875 (Sysmex Corp., 1999) has gone furthest, with 7 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 | — |
What is it indicated for?
The SE/RAM-1 is an In Vitro device for whole blood cell analysis in clinical laboratories. The SE-9000 portion is intended for blood cell analysis; the RAM-1 portion is intended for automated reticulocyte analysis. The instrument is a screening device for identifying abnormal blood specimens. Medical technologists are responsible for final review of abnormal cells.
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/K964375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964375: Sysmex SE/Ram-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964375
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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