510(k) · Cleared
Recalled · Class II · 2018Pathfast CK-MB-II, Pathfast Myo-II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitsubishi Kagaku Iatron · JHX Fluorometric Method, Cpk Or Isoenzymes
Cleared on Aug 17, 2009 after a 459-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 17, 2009
- Review
- 459 days
- Class
- Class II
- Product code
- JHX
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK081360 Pathfast CK-MB-II, Pathfast Myo-IIMitsubishi Kagaku Iatron · 2009
- Descendant · cites it directly · 0 of its ownK130628 Pathfast CK-MB-II CalibratorsMitsubishi Chemical Medience Corporation · 2013
Most influential descendants
Showing 1 of 1 · See all- K130628Pathfast CK-MB-II CalibratorsMitsubishi Chemical Medience Corporation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081360 | Pathfast CK-MB-II, Pathfast Myo-II | Mitsubishi Kagaku Iatron | 2009 | — |
| +1 | K130628 | Pathfast CK-MB-II Calibrators | Mitsubishi Chemical Medience Corporation | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130628 | Pathfast CK-MB-II Calibrators | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2018 | Class II | Z-3185-2018 | Process control | A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. If the cartridge with leakage is used, higher measurement value as low as +12% and no higher than +20% bias may be… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K130628 (Mitsubishi Chemical Medience Corporation, 2013) has gone furthest, with 0 descendants 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. 2009, this device’s year, is highlighted.
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 | — |
What is it indicated for?
PATHFAST CK-MB-Il test is an in vitro diagnostic test for the quantitative measurement of creatine kinase-MB in heparinized or EDTA whole blood and plasma. Measurements of CK-MB are used in the aid of diagnosis of acute myocardial infarction. This method is for use in clinical laboratory or point of care (POC) settings. The kit includes the reagent cartridges and calibrators. PATHFAST Myo-Il test is an in vitro diagnostic test for the quantitative…
Read the full statement (121 words)
PATHFAST CK-MB-Il test is an in vitro diagnostic test for the quantitative measurement of creatine kinase-MB in heparinized or EDTA whole blood and plasma. Measurements of CK-MB are used in the aid of diagnosis of acute myocardial infarction. This method is for use in clinical laboratory or point of care (POC) settings. The kit includes the reagent cartridges and calibrators.
PATHFAST Myo-Il test is an in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized or EDTA whole blood and plasma. Measurements of myoglobin are used to assist in the aid of diagnosis of myocardial infarction (MI). This method is for use in clinical laboratory or point of care (POC) settings. The kit includes the reagent cartridges and calibrators.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K081360 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081360: Pathfast CK-MB-II, Pathfast Myo-II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081360
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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