510(k) · Cleared
ClearedThermo Scientific Mas Omni-Cardio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corporation · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Aug 31, 2012 as substantially equivalent to K040880 (Medical Analysis Systems, Inc., 2004) and 1 other predicate after a 31-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Aug 31, 2012
- Review
- 31 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K040880 (2004). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK040880 Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels…Medical Analysis Systems, Inc. · 2004
- This deviceK122291 Thermo Scientific Mas Omni-CardioMicrogenics Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040880 | Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3 | Medical Analysis Systems, Inc. | 2004 | — |
| 0 (this device) | K122291 | Thermo Scientific Mas Omni-Cardio | Microgenics Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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 JJY? 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? (2)
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 |
|---|---|---|---|
| * | K040880 | Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3Summary page 1…gally Marketed Device to Which Equivalency is Claimed The -Thermo Scientific MAS® Omni*CARDIO is substantially equivalent to the previously cleared MAS® Cardiolmmune TL (K040880) and MAS® Cardiolmmune XL (K061196). Device Description Each MAS® Omni*CARDIO control kit is packaged in a plastic clamnshell co… | 2004 |
| * | K061196 | Cardioimmune XL Cardiac Marker ControlSummary page 1…valency is Claimed The -Thermo Scientific MAS® Omni*CARDIO is substantially equivalent to the previously cleared MAS® Cardiolmmune TL (K040880) and MAS® Cardiolmmune XL (K061196). Device Description Each MAS® Omni*CARDIO control kit is packaged in a plastic clamnshell container with a product insert and v… | 2006 |
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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
MAS® Omni-CARDIO
Thermo Scientific MAS® Omni*CARDlOI is intended for use in the clinical. laboratory as an assayed control serum for monitoring assay conditions related to cardiac and associated critical marker determinations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122291 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122291: Thermo Scientific Mas Omni-Cardio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122291
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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