510(k) · Cleared
ClearedCora (Coagulation Resonance Analysis) System with Platelet Mapping Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coramed Technologies, LLC · JOZ System, Automated Platelet Aggregation
Cleared on Jan 3, 2015 as substantially equivalent to K041502 (Haemoscope Corp., 2004) after a 270-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Jan 3, 2015
- Review
- 270 days
- Class
- Class II
- Product code
- JOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041502 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK041502 Thrombelastograph (Teg) Platelet Mapping AssayHaemoscope Corp. · 2004 · Recalled
- This deviceK140893 Cora (Coagulation Resonance Analysis) System with Platelet Mapping…Coramed Technologies, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041502 | Thrombelastograph (Teg) Platelet Mapping Assay | Haemoscope Corp. | 2004 | 1 |
| 0 (this device) | K140893 | Cora (Coagulation Resonance Analysis) System with Platelet Mapping Assay | Coramed Technologies, LLC | 2015 | — |
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 JOZ? 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 JOZ device
- #1 K191364 T-TAS 01 Total Thrombus-formation Analysis…score -0.6 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K041502 | Thrombelastograph (Teg) Platelet Mapping AssaySummary page 4…ood Hemostasis System Classification Name: 21CFR 864.5700 Automated Platelet Aggregation System PREDICATE DEVICE o Thrombelastograph® (TEG® PlateletMapping Assay), K041502, Product Code JOZ (System, Automated Platelet Aggregation), Haemoscope Corporation CORA System PlateletMap… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 a recall.
How does its category compare?
All JOZ devicesJOZ System, Automated Platelet Aggregation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JOZ
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JOZ
Too few JOZ 510(k)s in any year since 2007 to give a median.
Recalls per year · JOZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOZ
3in 2025
MAUDE reports naming product code JOZ, 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 | 1 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 1 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 1 |
| 2025 | 0 | — | 1 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CORA PlateletMapping System consists of the CORA analyzer and the CORA PlateletMapping Assay Cartridge. The CORA Platelet Mapping System is intended for in vitro diagnostic use to provide qualitative assessment of platelet function. The CORA System records the kinetic changes in a sample of heparinized whole blood as the sample clots. The CORA System PlateletMapping Assay Cartridge provides four channels of dried-in-place reagents, HKH (Kaolin with…
Read the full statement (187 words)
The CORA PlateletMapping System consists of the CORA analyzer and the CORA PlateletMapping Assay Cartridge. The CORA Platelet Mapping System is intended for in vitro diagnostic use to provide qualitative assessment of platelet function. The CORA System records the kinetic changes in a sample of heparinized whole blood as the sample clots.
The CORA System PlateletMapping Assay Cartridge provides four channels of dried-in-place reagents, HKH (Kaolin with Heparinase), Activator F, AA and ADP (one reagent in each channel). In combination, MA parameter results from these four reagents are used to calculate the parameters platelet % Inhibition and % Aggregation for AA and ADP.
Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests.
The CORA System with CORA PlateletMapping Assay Cartridge is indicated for use with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluation with the CORA PlateletMapping System is used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140893: Cora (Coagulation Resonance Analysis) System with Platelet Mapping Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140893
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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