510(k) · Cleared
ClearedAlloMap Heart Molecular Expression Testing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caredx, Inc. · OJQ Cardiac Allograft Gene Expression Profiling Test System
Cleared on Sep 13, 2023 as substantially equivalent to DEN080007 (Xdx, 2008) after a 464-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Sep 13, 2023
- Review
- 464 days
- Class
- Class II
- Product code
- OJQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN080007 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backDEN080007 Allomap Molecular Expression TestingXdx · 2008
- This deviceK221640 AlloMap Heart Molecular Expression TestingCaredx, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN080007 | Allomap Molecular Expression Testing | Xdx | 2008 | — |
| 0 (this device) | K221640 | AlloMap Heart Molecular Expression Testing | Caredx, Inc. | 2023 | — |
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 OJQ? 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 |
|---|---|---|---|
| * | DEN080007 | Allomap Molecular Expression Testing Our reading of the summary gave K073482, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN080007, Allomap Molecular Expression Testing (Xdx), granted Aug 26, 2008; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2008 |
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 no recall.
How does its category compare?
All OJQ devicesOJQ Cardiac Allograft Gene Expression Profiling Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OJQ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OJQ
Too few OJQ 510(k)s in any year since 2007 to give a median.
Recalls per year · OJQ
No recall names OJQ since 2007.
Adverse event reports per year · OJQ
No MAUDE report names OJQ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
AlloMap Heart Molecular Expression Testing is an In Vitro Diagnostic Multivariate Index assay (IVDMIA) test service, performed in a single laboratory, assessing the gene expression profile of RNA isolated from peripheral blood mononuclear cells (PBMC). AlloMap Heart Testing is intended to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (ACR) at the time of testing in conjunction with standard clinical assessment.
Indicated for use in heart transplant recipients:
• 15 years of age or older
• At least 2 months (≥55 days) post-transplant
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221640 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221640: AlloMap Heart Molecular Expression Testing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221640
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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