510(k) · Cleared
ClearedAccess CK-MB on the Access Immunoassay Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JHX Fluorometric Method, Cpk Or Isoenzymes
Cleared on Mar 20, 2000 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Mar 20, 2000
- Review
- 17 days
- Class
- Class II
- Product code
- JHX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK000716 Access CK-MB on the Access Immunoassay AnalyzerBeckman Coulter, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK030012 CK-MB and CK-MB Calibrators on the Access Immunoassay Systems…Beckman Coulter, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK234005 Access CK-MBBeckman Coulter, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK033155 Biocentrex Cardiac PanelBiocentrex · 2004
Most influential descendants
Showing 3 of 3 · See all- K030012CK-MB and CK-MB Calibrators on the Access Immunoassay Systems, Models 386371 and 386372Beckman Coulter, Inc. · 2003 · cites it directly1descendant
- K234005Access CK-MBBeckman Coulter, Inc. · 2024 · 2 generations on0descendants
- K033155Biocentrex Cardiac PanelBiocentrex · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000716 | Access CK-MB on the Access Immunoassay Analyzer | Beckman Coulter, Inc. | 2000 | — |
| +1 | K030012 | CK-MB and CK-MB Calibrators on the Access Immunoassay Systems, Models 386371… | Beckman Coulter, Inc. | 2003 | — |
| +2 | K234005 | Access CK-MB | Beckman Coulter, Inc. | 2024 | — |
| +1 | K033155 | Biocentrex Cardiac Panel | Biocentrex | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2024 | 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 JHX? 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 JHX device
- #1 K234005 Access CK-MBscore 7.2 · 2 generations · no Class I recall
- #2 Held for the reportin 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? (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, K030012 (Beckman Coulter, Inc., 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JHX devicesJHX Fluorometric Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JHX
Too few JHX 510(k)s in any year since 2007 to give a median.
Recalls per year · JHX
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHX
1in 2025
MAUDE reports naming product code JHX, 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 | 2 |
| 2008 | 0 | — | 1 | 6 |
| 2009 | 1 | — | 1 | 40 |
| 2010 | 0 | — | 0 | 27 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 1 | — | 4 | 18 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 0 | — | 2 | 8 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K000716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000716: Access CK-MB on the Access Immunoassay Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000716
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026