510(k) · Cleared
ClearedAmax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax Destiny Coagulation Analyzer-Refurbished
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Diagnostics, Inc. · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Aug 30, 2002 after a 141-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Aug 30, 2002
- Review
- 141 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK021162 Amax Density Coagulation Analyzer, Amax Denstiny Coagulation…Sigma Diagnostics, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK082248 Sta Satellite Automated Multi-Parameter AnalyzerDiagnostica Stago, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK253658 STA Satellite Max®Diagnostica Stago, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK083896 Destiny Max Coagulation AnalyzerTrinity Biotech · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021162 | Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax… | Sigma Diagnostics, Inc. | 2002 | — |
| +1 | K082248 | Sta Satellite Automated Multi-Parameter Analyzer | Diagnostica Stago, Inc. | 2008 | 2 |
| +2 | K253658 | STA Satellite Max® | Diagnostica Stago, Inc. | 2026 | — |
| +1 | K083896 | Destiny Max Coagulation Analyzer | Trinity Biotech | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2026 | 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 JPA? 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 JPA device
- #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | — | AMAX 190 Coagulation Analyzer Named without a submission number |
What descends from it? (3)
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, K082248 (Diagnostica Stago, Inc., 2008) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JPA devicesJPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JPA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JPA
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPA
11in 2025
MAUDE reports naming product code JPA, 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 | 1 | — | 1 | 1,744 |
| 2008 | 2 | — | 0 | 918 |
| 2009 | 6 | 91 | 0 | 1,363 |
| 2010 | 1 | — | 6 | 727 |
| 2011 | 1 | — | 4 | 161 |
| 2012 | 0 | — | 1 | 52 |
| 2013 | 1 | — | 0 | 43 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 45 |
| 2016 | 6 | 114 | 3 | 6 |
| 2017 | 4 | 117 | 0 | 15 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 3 | 175 | 0 | 27 |
| 2020 | 0 | — | 1 | 18 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 3 | 506 | 0 | 11 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 3 | 30 | 0 | 11 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The AMAX DestinyTM Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021162 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021162: Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax Destiny Coagulation Analyzer-Refurbished.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021162
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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