510(k) · Cleared
ClearedChrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel
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 Dec 2, 2016 as substantially equivalent to K050265 (Chrono-Log Corp., 2005) after a 204-day review. Its family tree reaches back 4 generations to 1983.
- Decided
- Dec 2, 2016
- Review
- 204 days
- Class
- Class II
- Product code
- JOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K830749 (1983). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK830749 Platelet AggregometerChrono-Log Corp. · 1983
- 3 generations backK962426 Chrono-Log Whole Blood Aggregometer (Wba) 591/592Chrono-Log Corp. · 1996
- 2 generations backK032951 Chrono-Log Whole Blood Aggregometer, Models 591A and 592AChrono-Log Corp. · 2004
- 1 generation backK050265 Chrono-Log Whole Blood Lumi-Aggregometer, Model 700Chrono-Log Corp. · 2005
- This deviceK161329 Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet…Chrono-Log Corp. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K830749 | Platelet Aggregometer | Chrono-Log Corp. | 1983 | — |
| −3 | K962426 | Chrono-Log Whole Blood Aggregometer (Wba) 591/592 | Chrono-Log Corp. | 1996 | — |
| −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 | — |
| 0 (this device) | K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer… | Chrono-Log Corp. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1996 | 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 |
|---|---|---|---|
| * | K050265 | Chrono-Log Whole Blood Lumi-Aggregometer, Model 700Summary page 5…or the determination of Platelet Aggregation in samples of PRP. The 490 4+4 is a modified Model 700. Substantial equivalency between the Model 490 4+4 and the Model 700 (K050265) currently in commercial distribution by Chrono-log Corp is claimed. The fundamental scientific technology of… | 2005 |
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 33 years and passes through 1 company; a new generation was cleared every 11.1 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K050265.
How does its category compare?
All JOZ devicesJOZ System, Automated Platelet Aggregation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 Model 490 4+4 Aggregometer is intended for use for in-vitro diagnostic use for measuring Platelet Aggregation in Platelet Rich Plasma.
This device is intended to be used in a clinical laboratory environment by laboratory technicians.
For use only with light transmission aggregometry assays cleared for use with the Chrono-log Platelet Aggregometry systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161329: Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161329
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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