510(k) · Cleared
ClearedChrono-Log Whole Blood Aggregometer (Wba) 591/592
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chrono-Log Corp. · JOZ System, Automated Platelet Aggregation
Cleared on Oct 22, 1996 as substantially equivalent to K830749 (Chrono-Log Corp., 1983) and 1 other predicate after a 120-day review. Its family tree reaches back 1 generation to 1983. 4 later devices descend from it.
- Decided
- Oct 22, 1996
- Review
- 120 days
- Class
- Class II
- Product code
- JOZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K830749 (1983). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK830749 Platelet AggregometerChrono-Log Corp. · 1983
- This deviceK962426 Chrono-Log Whole Blood Aggregometer (Wba) 591/592Chrono-Log Corp. · 1996
- Descendant · cites it directly · 3 of its ownK032951 Chrono-Log Whole Blood Aggregometer, Models 591A and 592AChrono-Log Corp. · 2004
- Descendant · 2 generations on · 2 of its ownK050265 Chrono-Log Whole Blood Lumi-Aggregometer, Model 700Chrono-Log Corp. · 2005
- Descendant · 3 generations on · 0 of its ownK161329 Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet…Chrono-Log Corp. · 2016
- Descendant · 3 generations on · 0 of its ownK103555 Multiplate 5.0 AggregometerVerum Diagnostica GmbH · 2012
Most influential descendants
Showing 4 of 4 · See all- K032951Chrono-Log Whole Blood Aggregometer, Models 591A and 592AChrono-Log Corp. · 2004 · cites it directly3descendants
- K050265Chrono-Log Whole Blood Lumi-Aggregometer, Model 700Chrono-Log Corp. · 2005 · 2 generations on2descendants
- K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelChrono-Log Corp. · 2016 · 3 generations on0descendants
- K103555Multiplate 5.0 AggregometerVerum Diagnostica GmbH · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830749 | Platelet Aggregometer | Chrono-Log Corp. | 1983 | — |
| 0 (this device) | K962426 | Chrono-Log Whole Blood Aggregometer (Wba) 591/592 | Chrono-Log Corp. | 1996 | — |
| +1 | K032951 | Chrono-Log Whole Blood Aggregometer, Models 591A and 592A | Chrono-Log Corp. | 2004 | — |
| +2 | K050265 | Chrono-Log Whole Blood Lumi-Aggregometer, Model 700 | Chrono-Log Corp. | 2005 | — |
| +3 | K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer… | Chrono-Log Corp. | 2016 | — |
| +3 | K103555 | Multiplate 5.0 Aggregometer | Verum Diagnostica GmbH | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
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 JOZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JOZ device
- #1 K191364 T-TAS 01 Total Thrombus-formation Analysis…score -0.5 · 3 generations · no Class I recall
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 | Decided |
|---|---|---|---|
| * | K830749 | Platelet AggregometerSummary page 1…d in this application, we have found the Chrono-log Whole Blood Aggregometer (WBA), Model 591/592 to be substantially equivalent to Chrono-log Whole Blood Aggregometer ( K830749) and Centocor AggreStat (K954997). Device Description: The Chrono-log WBA, Model 591/592 uses electrical impedance to measure p… | 1983 |
| * | K954997 | Centocor Aggrestat, Collagen Reagent, Control ReagentSummary page 1…und the Chrono-log Whole Blood Aggregometer (WBA), Model 591/592 to be substantially equivalent to Chrono-log Whole Blood Aggregometer ( K830749) and Centocor AggreStat (K954997). Device Description: The Chrono-log WBA, Model 591/592 uses electrical impedance to measure platelet aggregation in a whole bl… | 1996 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032951 | Chrono-Log Whole Blood Aggregometer, Models 591A and 592A | 2004 | 3 |
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?
How does its category compare?
All JOZ devicesJOZ System, Automated Platelet Aggregation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOZ
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JOZ
Too few JOZ 510(k)s in any year since 2007 to give a median.
Recalls per year · JOZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOZ
3in 2025
MAUDE reports naming product code JOZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 1 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 1 |
| 2025 | 0 | — | 1 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Chrono-log WBA, Model 591/592 is intended for determination of platelet function in a whole blood specimen.
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/K962426 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962426: Chrono-Log Whole Blood Aggregometer (Wba) 591/592.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962426
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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