510(k) · Cleared
ClearedKit, Platelet Aggregation Reagent (#390)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chrono-Log Corp. · GHR Reagent, Platelet Aggregation
Cleared on Jul 19, 1976 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Jul 19, 1976
- Review
- 13 days
- Class
- Class II
- Product code
- GHR
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK760198 Kit, Platelet Aggregation Reagent (#390)Chrono-Log Corp. · 1976
- Descendant · cites it directly · 0 of its ownK013596 Modification to Ultegra System Rapid Platelet Function Assay - Trap…Accumetrics, Inc. · 2002 · Recalled
- Descendant · cites it directly · 0 of its ownK992531 Ultegra System Analyzer, Ultegra System Rpfa-Trap Test Cartidges…Accumetrics, Inc. · 1999 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K760198 | Kit, Platelet Aggregation Reagent (#390) | Chrono-Log Corp. | 1976 | — |
| +1 | K013596 | Modification to Ultegra System Rapid Platelet Function Assay - Trap (Rpfa-Trap) | Accumetrics, Inc. | 2002 | 2 |
| +1 | K992531 | Ultegra System Analyzer, Ultegra System Rpfa-Trap Test Cartidges, Ultegra… | Accumetrics, Inc. | 1999 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K013596 (Accumetrics, Inc., 2002) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GHR devicesGHR Reagent, Platelet Aggregation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K760198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K760198: Kit, Platelet Aggregation Reagent (#390).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K760198
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026