510(k) · Cleared
ClearedChrono-Log Whole Blood Aggregometer, Models 591A and 592A
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 Apr 2, 2004 as substantially equivalent to K962426 (Chrono-Log Corp., 1996) after a 193-day review. Its family tree reaches back 2 generations to 1983. 3 later devices descend from it.
- Decided
- Apr 2, 2004
- Review
- 193 days
- Class
- Class II
- Product code
- JOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K830749 (1983). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK830749 Platelet AggregometerChrono-Log Corp. · 1983
- 1 generation backK962426 Chrono-Log Whole Blood Aggregometer (Wba) 591/592Chrono-Log Corp. · 1996
- This deviceK032951 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 · 2 generations on · 0 of its ownK161329 Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet…Chrono-Log Corp. · 2016
- Descendant · 2 generations on · 0 of its ownK103555 Multiplate 5.0 AggregometerVerum Diagnostica GmbH · 2012
Most influential descendants
Showing 3 of 3 · See all- K050265Chrono-Log Whole Blood Lumi-Aggregometer, Model 700Chrono-Log Corp. · 2005 · cites it directly2descendants
- K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelChrono-Log Corp. · 2016 · 2 generations on0descendants
- K103555Multiplate 5.0 AggregometerVerum Diagnostica GmbH · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830749 | Platelet Aggregometer | Chrono-Log Corp. | 1983 | — |
| −1 | K962426 | Chrono-Log Whole Blood Aggregometer (Wba) 591/592 | Chrono-Log Corp. | 1996 | — |
| 0 (this device) | 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 | — |
| +2 | K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer… | Chrono-Log Corp. | 2016 | — |
| +2 | 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 |
|---|---|---|
| 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 -0.6 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K962426 | Chrono-Log Whole Blood Aggregometer (Wba) 591/592Summary page 1…Whole Blood Aggregometer with Disposable Electrodes (WBA), Model 591 A/592A to be substantially equivalent to Chrono-log Whole Blood Aggregometer ( WBA) Model 59 1/592 (K962426). 11.1 Device Description: The Chrono-log WBA, Model 591 A/592A uses electrical impedance to measure platelet aggregation in a… | 1996 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050265 | Chrono-Log Whole Blood Lumi-Aggregometer, Model 700 | 2005 | 2 |
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 21 years and passes through 1 company; a new generation was cleared every 13.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K050265 (Chrono-Log Corp., 2005) has gone furthest, with 2 descendants of its own.
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?
For Platelet Function testing of Whole Blood specimens using Impedance Aggregometry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032951: Chrono-Log Whole Blood Aggregometer, Models 591A and 592A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032951
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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