510(k) · Cleared
ClearedPlateletworks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Array Medical, Inc. · JOZ System, Automated Platelet Aggregation
Cleared on Dec 1, 1999 as substantially equivalent to K822733 (Sigma Chemical Co., 1982) and 4 other predicates after a 295-day review. Its family tree reaches back 1 generation to 1977. 1 later device descends from it.
- Decided
- Dec 1, 1999
- Review
- 295 days
- Class
- Class II
- Product code
- JOZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K771198 (1977). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K023761Plateletworks, Models PW-a, PW-CHelena Laboratories · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771198 | Lumi-Aggregometer | Chrono-Log Corp. | 1977 | — |
| 0 (this device) | K990398 | Plateletworks | Array Medical, Inc. | 1999 | — |
| +1 | K023761 | Plateletworks, Models PW-a, PW-C | Helena Laboratories | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 2 | 0 |
| 1985 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (5)
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 |
|---|---|---|---|
| * | K822733 | Sigma Reagent System NO. 885Summary page 1…orks Common Name: Platelet Aggregation Assay Classification Name: System, Automatic Platelet Aggregation Legally Marketed Device: Sigma Platelet Aggregation Reagents, K822733, K832929 Chrono-log Platelet Aggregometer, K77198, K830749, K851025 Device Description: Plateletworks is a unitized screening as… | 1982 |
| * | K832929 | Ristocetin Platelet Aggrega-Reagent TestSummary page 1…mon Name: Platelet Aggregation Assay Classification Name: System, Automatic Platelet Aggregation Legally Marketed Device: Sigma Platelet Aggregation Reagents, K822733, K832929 Chrono-log Platelet Aggregometer, K77198, K830749, K851025 Device Description: Plateletworks is a unitized screening assay for d… | 1983 |
| * | K771198 | Lumi-AggregometerSummary page 2…previously cleared under Document Control # K822733 and K832929, used on the Chrono-log Platelet Aggregometer (Model 560-VS), previously cleared under Document Control # K771198, K830749 and K851025. These products are currently in commercial distribution by Sigma Diagnostics, St. Louis, MO and Chrono-log… | 1977 |
| * | K830749 | Platelet AggregometerSummary page 1…n Name: System, Automatic Platelet Aggregation Legally Marketed Device: Sigma Platelet Aggregation Reagents, K822733, K832929 Chrono-log Platelet Aggregometer, K77198, K830749, K851025 Device Description: Plateletworks is a unitized screening assay for determining platelet aggregation in a whole blood sa… | 1983 |
| * | K851025 | Aggro/Link Computer InterfaceSummary page 1…ystem, Automatic Platelet Aggregation Legally Marketed Device: Sigma Platelet Aggregation Reagents, K822733, K832929 Chrono-log Platelet Aggregometer, K77198, K830749, K851025 Device Description: Plateletworks is a unitized screening assay for determining platelet aggregation in a whole blood sample usin… | 1985 |
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 |
|---|---|---|---|
| K023761 | Plateletworks, Models PW-a, PW-C | 2003 | 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?
- None of the 5 ancestors has a recall.
- Of its descendants, K023761 (Helena Laboratories, 2003) has gone furthest, with 0 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?
Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood samples taken during cardiac interventional procedures as measured by a change in platelet count due to activation of functional platelets. It may be used at the point-of-care on the Ichor hematology analyzer as a screening tool for the detection of trends suggestive of platelet dysfunction. Any abnormal baseline or otherwise suspicious result would require repeating the Plateletworks test procedure and/or further additional investigation with more definitive test methods, including conventional platelet aggregometry.
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/K990398 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990398: Plateletworks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990398
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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