510(k) · Cleared
Recalled · Class II · 2019Aggreguide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aggredyne, Inc. · JOZ System, Automated Platelet Aggregation
Cleared on Dec 20, 2013 as substantially equivalent to K042423 (Accumetrics, Inc., 2004) after a 518-day review. Its family tree reaches back 2 generations to 1983. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 20, 2013
- Review
- 518 days
- Class
- Class II
- Product code
- JOZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K830749 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK830749 Platelet AggregometerChrono-Log Corp. · 1983
- 1 generation backK042423 Verifynow-Aspirin AssayAccumetrics, Inc. · 2004
- This deviceK122162 AggreguideAggredyne, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK163274 AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentAggredyne, Inc. · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentAggredyne, Inc. · 2017 · cites it directly0descendants
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 | K042423 | Verifynow-Aspirin Assay | Accumetrics, Inc. | 2004 | — |
| 0 (this device) | K122162 | Aggreguide | Aggredyne, Inc. | 2013 | — |
| +1 | K163274 | AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument | Aggredyne, Inc. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K042423 | Verifynow-Aspirin AssaySummary page 1…n Number: 864.5700 Product Code: JOZ 3. Predicate Devices: The predicate is the Accumetrics VerifyNow-Aspirin Assay [K042423]. 4. Description of Device: The AggreGuide A-1 00 is a laser light scattering system that detects the level… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163274 | AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 23, 2019 | Class II | Z-1639-2022 | Software design | The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1 being erased. Due to this issue, the target RPM for the assay is 0 and the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 21.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K163274 (Aggredyne, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K042423.
How does its category compare?
All JOZ devicesJOZ System, Automated Platelet Aggregation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 AggreGuide A-i 00 AA Assay is a qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion by those 18 yearn of age or older in 3.2% citrated venous whole blood using the AggreGuide A-i 00 instrument. For professional use. This test is not for use in patients with underlying congenital platelet abnormalities, patients with nan-aspirin induced acquired platelet abnormalities or in patients receiving non-aspirin anti-platelet agents. The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122162: Aggreguide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122162
Report an extraction error
Are you the manufacturer?
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