510(k) · Cleared
ClearedElecsys CK-MB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JHW U.V. Method, Cpk Isoenzymes
Cleared on Jun 11, 1996 as substantially equivalent to K931172 (Abbott Laboratories, 1993) after a 54-day review. Its family tree reaches back 1 generation to 1993. 57 later devices descend from it.
- Decided
- Jun 11, 1996
- Review
- 54 days
- Class
- Class II
- Product code
- JHW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931172 (1993). 57 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- This deviceK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- Descendant · cites it directly · 52 of its ownK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- Descendant · 2 generations on · 51 of its ownK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- Descendant · 3 generations on · 41 of its ownK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- Descendant · 4 generations on · 20 of its ownK072437 Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008
- Descendant · 4 generations on · 19 of its ownK033937 Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K962575Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996 · cites it directly52descendants
- K983492Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998 · 2 generations on51descendants
- K032089Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003 · 3 generations on41descendants
- K072437Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008 · 4 generations on20descendants
- K033937Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| 0 (this device) | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| +1 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| +2 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| +3 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| +4 | K072437 | Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset | Roche Diagnostics | 2008 | — |
| +4 | K033937 | Elecsys Precicontrol Multianalyte | Roche Diagnostics Corp. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 JHW? 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? (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 |
|---|---|---|---|
| * | K931172 | Imx (R) Stat CK-MBSummary page 1…n Chambers Date Prepared: April 12, 1996 Proprietary name: Elecsys® CK-MB Common name: creatine kinase test We claim substantial equivalence to the Abbott IMx CK-MB (K931172) The Elecsys® CK-MB test principle is based on a two-step sandwich with Streptavidin microparticles and electrochemiluminescence… | 1993 |
What descends from it? (57)
See all 572 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?
- Its one ancestor has no recall.
- Of its descendants, K962575 (Boehringer Mannheim Corp., 1996) has gone furthest, with 52 descendants of its own.
How does its category compare?
All JHW devicesJHW U.V. Method, Cpk Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHW
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JHW
Too few JHW 510(k)s in any year since 2007 to give a median.
Recalls per year · JHW
No recall names JHW since 2007.
Adverse event reports per year · JHW
1in 2024
MAUDE reports naming product code JHW, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma.
A creatine phosphokinase / creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine kinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961501 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961501: Elecsys CK-MB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961501
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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