510(k) · Cleared

Cleared

Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500

K981950510(k) TraditionalCleared Nov 3, 1998153-day reviewClass II21 CFR 864.5200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sysmex Corp. · GKL Counter, Cell, Automated (Particle Counter)

Cleared on Nov 3, 1998 as substantially equivalent to K964375 (Sysmex Corp., 1997) and 1 other predicate after a 153-day review. Its family tree reaches back 2 generations to 1991.

Decided: Nov 3, 1998
Review: 153 days
Class: Class II
Product code: GKL
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K912494 (1991). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK912494 Sysmex (TM) R-3000 Automated Reticulocyte AnalyzerToa Medical Electronics USA, Inc. · 1991
1 generation backK964375 Sysmex SE/Ram-1Sysmex Corp. · 1997
This deviceK981950 Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500Sysmex Corp. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K912494	Sysmex (TM) R-3000 Automated Reticulocyte Analyzer	Toa Medical Electronics USA, Inc.	1991	—
−1	K964375	Sysmex SE/Ram-1	Sysmex Corp.	1997	—
0 (this device)	K981950	Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500	Sysmex Corp.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

FIG. 1 — Lineage of K981950, 1991–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K964375	Sysmex SE/Ram-1 Summary page 4 …O O O 1 8 Sysmex™ Automated Reticulocyte Analyzer R-3500 Table 1 Comparative Features between R-3500 and RAM-1/R-3000 Features R-3500 SE/RAM-1 R-3000 K964375 K912494 FDA Clearance Date -—- Mar. 13, 1997 Sept. 10, 1991 Intended Use Automated Automated Automated reticulocyte counter for…	Sysmex Corp.	1997	—
*	K912494	Sysmex (TM) R-3000 Automated Reticulocyte Analyzer Summary page 4 …8 Sysmex™ Automated Reticulocyte Analyzer R-3500 Table 1 Comparative Features between R-3500 and RAM-1/R-3000 Features R-3500 SE/RAM-1 R-3000 K964375 K912494 FDA Clearance Date -—- Mar. 13, 1997 Sept. 10, 1991 Intended Use Automated Automated Automated reticulocyte counter for in vitro…	Toa Medical Electronics USA, Inc.	1991	—
†	K971736	Sysmex Immature Reticulocyte Fraction (Irf) Parameter	Sysmex Corp.	1997	—

Also cleared against K964375: 1 other device →

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?

The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K964375.

How does its category compare?

All GKL devices

GKL Counter, Cell, Automated (Particle Counter): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKL

1in 2016

2007high 1 (2007) · low 0 (2008)2026

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

2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GKL

1in 2025

2007high 31 (2011) · low 0 (2010)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 R-3500 is as a fully automated reticulocyte analyzer 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/K981950 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981950: Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981950

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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