510(k) · Cleared
ClearedPlateletworks Arachidonic Acid, Model PW-Aca
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Helena Laboratories · GHR Reagent, Platelet Aggregation
Cleared on Feb 23, 2007 after a 225-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 23, 2007
- Review
- 225 days
- Class
- Class II
- Product code
- GHR
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GHR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All GHR devicesGHR Reagent, Platelet Aggregation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GHR
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GHR
Too few GHR 510(k)s in any year since 2007 to give a median.
Recalls per year · GHR
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GHR
No MAUDE report names GHR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 2 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Plateletworks Arachidonic Acid (PW-ACA) is an in vitro diagnostic screening test on whole blood for the qualitative determination of platelet inhibition by aspirin which inhibit arachidonic acid induced platelet aggregation. The change in platelet count due to activation and aggregation of functional platelets is measured using an electronic impedance-base cell counter.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061991 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061991: Plateletworks Arachidonic Acid, Model PW-Aca.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061991
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026