510(k) · Cleared

Cleared

Platelet Aggregometer

K830749510(k) TraditionalCleared May 16, 198368-day reviewClass II21 CFR 864.6675

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

Chrono-Log Corp. · JBX Aggregrometer, Platelet

Cleared on May 16, 1983 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.

Decided: May 16, 1983
Review: 68 days
Class: Class II
Product code: JBX
Recalls: None
Predicates: 0

20 later devices descend from it, 9 citing it directly.

This deviceK830749 Platelet AggregometerChrono-Log Corp. · 1983
Descendant · cites it directly · 4 of its ownK962426 Chrono-Log Whole Blood Aggregometer (Wba) 591/592Chrono-Log Corp. · 1996
Descendant · cites it directly · 3 of its ownK042423 Verifynow-Aspirin AssayAccumetrics, Inc. · 2004
Descendant · 2 generations on · 3 of its ownK032951 Chrono-Log Whole Blood Aggregometer, Models 591A and 592AChrono-Log Corp. · 2004
Descendant · cites it directly · 2 of its ownK050265 Chrono-Log Whole Blood Lumi-Aggregometer, Model 700Chrono-Log Corp. · 2005
Descendant · cites it directly · 2 of its ownK051231 Verifynow-P2Y12 AssayAccumetrics, Inc. · 2005 · Recalled

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

1996high 2 (1999) · low 0 (1998)2026

Most influential descendants

Showing 5 of 20 · See all

K962426Chrono-Log Whole Blood Aggregometer (Wba) 591/592Chrono-Log Corp. · 1996 · cites it directly4descendants
K042423Verifynow-Aspirin AssayAccumetrics, Inc. · 2004 · cites it directly3descendants
K032951Chrono-Log Whole Blood Aggregometer, Models 591A and 592AChrono-Log Corp. · 2004 · 2 generations on3descendants
K050265Chrono-Log Whole Blood Lumi-Aggregometer, Model 700Chrono-Log Corp. · 2005 · cites it directly2descendants
K051231Verifynow-P2Y12 AssayAccumetrics, Inc. · 2005 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K830749	Platelet Aggregometer	Chrono-Log Corp.	1983	—
+1	K962426	Chrono-Log Whole Blood Aggregometer (Wba) 591/592	Chrono-Log Corp.	1996	—
+1	K042423	Verifynow-Aspirin Assay	Accumetrics, Inc.	2004	—
+2	K032951	Chrono-Log Whole Blood Aggregometer, Models 591A and 592A	Chrono-Log Corp.	2004	—
+1	K050265	Chrono-Log Whole Blood Lumi-Aggregometer, Model 700	Chrono-Log Corp.	2005	—
+1	K051231	Verifynow-P2Y12 Assay	Accumetrics, Inc.	2005	3

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
1999	2	0
2002	2	0
2003	1	0
2004	2	0
2005	2	0
2006	1	0
2007	1	0
2012	1	0
2013	1	0
2015	1	0
2016	1	0
2017	1	0
2019	1	0
2020	1	0

FIG. 1 — Lineage of K830749, 1983–2020Source: 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 JBX? 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? (20)

See all 20

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K962426	Chrono-Log Whole Blood Aggregometer (Wba) 591/592	Chrono-Log Corp.	1996	4
K042423	Verifynow-Aspirin Assay	Accumetrics, Inc.	2004	3
K050265	Chrono-Log Whole Blood Lumi-Aggregometer, Model 700	Chrono-Log Corp.	2005	2
K051231	Verifynow-P2Y12 Assay	Accumetrics, Inc.	2005	2
K970505	Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa…	Dade Intl., Inc.	1997	2
K990398	Plateletworks	Array Medical, Inc.	1999	1
K012701	Ultegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa)	Accumetrics, Inc.	2002	0
K013596	Modification to Ultegra System Rapid Platelet Function Assay - Trap (Rpfa-Trap)	Accumetrics, Inc.	2002	0
K992531	Ultegra System Analyzer, Ultegra System Rpfa-Trap Test Cartidges, Ultegra System…	Accumetrics, Inc.	1999	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, K962426 (Chrono-Log Corp., 1996) has gone furthest, with 4 descendants of its own.

How does its category compare?

All JBX devices

JBX Aggregrometer, Platelet: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JBX

FDA has decided no JBX device since 2007.

Median 510(k) review, days · JBX

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

Recalls per year · JBX

No recall names JBX since 2007.

Adverse event reports per year · JBX

1in 2016

2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code JBX, 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	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	1
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K830749 · printed Nov 4, 2026

Cite this page

510(k) Report. “K830749: Platelet Aggregometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K830749

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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