510(k) · Cleared
ClearedLumi-Aggregometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chrono-Log Corp. · JBY Aggregometer, Platelet, Photo-Optical Scanning
Cleared on Aug 2, 1977 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 2, 1977
- Review
- 32 days
- Class
- Class II
- Product code
- JBY
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK771198 Lumi-AggregometerChrono-Log Corp. · 1977
- Descendant · cites it directly · 2 of its ownK970505 Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine…Dade Intl., Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK060489 Dade Pfa-100 Platelet Function Analyzer and ReagentsDade Behring, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK990398 PlateletworksArray Medical, Inc. · 1999
- Descendant · 3 generations on · 0 of its ownK191364 T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL…Fujimori Kogyo, Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK023761 Plateletworks, Models PW-a, PW-CHelena Laboratories · 2003
Most influential descendants
Showing 5 of 5 · See all- K970505Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa…Dade Intl., Inc. · 1997 · cites it directly2descendants
- K060489Dade Pfa-100 Platelet Function Analyzer and ReagentsDade Behring, Inc. · 2006 · 2 generations on1descendant
- K990398PlateletworksArray Medical, Inc. · 1999 · cites it directly1descendant
- K191364T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL…Fujimori Kogyo, Co., Ltd. · 2020 · 3 generations on0descendants
- K023761Plateletworks, Models PW-a, PW-CHelena Laboratories · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K771198 | Lumi-Aggregometer | Chrono-Log Corp. | 1977 | — |
| +1 | K970505 | Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test… | Dade Intl., Inc. | 1997 | — |
| +2 | K060489 | Dade Pfa-100 Platelet Function Analyzer and Reagents | Dade Behring, Inc. | 2006 | — |
| +1 | K990398 | Plateletworks | Array Medical, Inc. | 1999 | — |
| +3 | K191364 | T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for… | Fujimori Kogyo, Co., Ltd. | 2020 | — |
| +2 | K023761 | Plateletworks, Models PW-a, PW-C | Helena Laboratories | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2020 | 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 JBY? 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? (5)
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, K970505 (Dade Intl., Inc., 1997) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JBY devicesJBY Aggregometer, Platelet, Photo-Optical Scanning: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JBY
FDA has decided no JBY device since 2007.
Median 510(k) review, days · JBY
Too few JBY 510(k)s in any year since 2007 to give a median.
Recalls per year · JBY
No recall names JBY since 2007.
Adverse event reports per year · JBY
No MAUDE report names JBY since 2007.
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 | 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 | — | 0 | 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/K771198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K771198: Lumi-Aggregometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K771198
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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