510(k) · Cleared

Cleared

Tri-Count 16

K902389510(k) TraditionalCleared Aug 22, 199084-day reviewClass II21 CFR 864.8625

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

Hematronix, Inc. · JCN Control, Cell Counter, Normal And Abnormal

Cleared on Aug 22, 1990 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Aug 22, 1990
Review: 84 days
Class: Class II
Product code: JCN
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK902389 Tri-Count 16Hematronix, Inc. · 1990
Descendant · cites it directly · 0 of its ownK091303 Liquichek Hematology-16 Control LV, Model: 295LVBio-Rad Laboratories · 2010

Most influential descendants

Showing 1 of 1 · See all

K091303Liquichek Hematology-16 Control LV, Model: 295LVBio-Rad Laboratories · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K902389	Tri-Count 16	Hematronix, Inc.	1990	—
+1	K091303	Liquichek Hematology-16 Control LV, Model: 295LV	Bio-Rad Laboratories	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K902389, 1990–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JCN? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K091303	Liquichek Hematology-16 Control LV, Model: 295LV	Bio-Rad Laboratories	2010	0

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, K091303 (Bio-Rad Laboratories, 2010) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JCN devices

JCN Control, Cell Counter, Normal And Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JCN

FDA has decided no JCN device since 2007.

Median 510(k) review, days · JCN

Too few JCN 510(k)s in any year since 2007 to give a median.

Recalls per year · JCN

No recall names JCN since 2007.

Adverse event reports per year · JCN

2in 2007

2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code JCN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	2
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K902389 · printed Nov 4, 2026

Cite this page

510(k) Report. “K902389: Tri-Count 16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K902389

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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