510(k) · Cleared
ClearedSysmex KX-21, Automated Hematology Analyzer
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 Aug 14, 1998 as substantially equivalent to K882370 (Toa Medical Electronics USA, Inc., 1988) after an 87-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Aug 14, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- GKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K882370 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK882370 Sysmex K-1000 18 Parameter, Auto. Hema AnalyzerToa Medical Electronics USA, Inc. · 1988
- This deviceK981761 Sysmex KX-21, Automated Hematology AnalyzerSysmex Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882370 | Sysmex K-1000 18 Parameter, Auto. Hema Analyzer | Toa Medical Electronics USA, Inc. | 1988 | — |
| 0 (this device) | K981761 | Sysmex KX-21, Automated Hematology Analyzer | Sysmex Corp. | 1998 | — |
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? (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 |
|---|---|---|---|
| * | K882370 | Sysmex K-1000 18 Parameter, Auto. Hema AnalyzerSummary page 2…hows the comparative features of the KX-21 to the Sysmex™ K-1000 and SF-3000. Comparative Features to K-1000 and SF-3000 Features KX-21 K-1000 SF-3000 (Submission #) (K882370) (K950508) FDA Clearance --- 25-Aug-88 3-Nov-95 Intended Use Automated blood Automated blood Automated blood cell counter for i… | 1988 |
| † | K950508 | Sysmex SF-3000 | 1995 |
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?
- Its one ancestor has no recall.
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 intended use of the Sysmex KX-21 is as an automated cell counter for in vitro
diagnostic use in clinical laboratories.
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/K981761 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981761: Sysmex KX-21, Automated Hematology Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981761
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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