510(k) · Cleared
ClearedSysmex SF-3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sysmex Corp. · FPK Tubing, Fluid Delivery
Cleared on Nov 3, 1995 after a 270-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Nov 3, 1995
- Review
- 270 days
- Class
- Class II
- Product code
- FPK
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK950508 Sysmex SF-3000Sysmex Corp. · 1995
- 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 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K950508 | Sysmex SF-3000 | Sysmex Corp. | 1995 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FPK? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992875 | Sysmex XE-2100, Automatated Hematology Analyzer | 1999 | 7 |
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, K992875 (Sysmex Corp., 1999) has gone furthest, with 7 descendants of its own.
How does its category compare?
All FPK devicesFPK Tubing, Fluid Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPK
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FPK
Too few FPK 510(k)s in any year since 2007 to give a median.
Recalls per year · FPK
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPK
30in 2025
MAUDE reports naming product code FPK, 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 | — | 0 | 29 |
| 2008 | 0 | — | 9 | 78 |
| 2009 | 0 | — | 0 | 92 |
| 2010 | 0 | — | 0 | 67 |
| 2011 | 0 | — | 0 | 112 |
| 2012 | 0 | — | 14 | 107 |
| 2013 | 1 | — | 1 | 29 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 1 | 15 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 30 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K950508 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950508: Sysmex SF-3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950508
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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