510(k) · Cleared
Recalled · 2007Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243, 973244
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · DDR Myoglobin, Antigen, Antiserum, Control
Cleared on Jun 28, 2002 as substantially equivalent to K000196 (Beckman Coulter, Inc., 2000) after a 71-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it. It has been recalled once.
- Decided
- Jun 28, 2002
- Review
- 71 days
- Class
- Class II
- Product code
- DDR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000196 (2000). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK000196 Access Myoglobin on the Access Immunoassay Analyzer, Models 33310…Beckman Coulter, Inc. · 2000
- This deviceK021229 Myoglobin and Myoglobin Calibrators on the Access Immunoassay…Beckman Coulter, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK231832 Access MyoglobinBeckman Coulter, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK080481 Access Immunoassay Systems Myoglobin and Access Immunoassay Systems…Beckman Coulter, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK062737 Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2007
Most influential descendants
Showing 3 of 3 · See all- K231832Access MyoglobinBeckman Coulter, Inc. · 2023 · cites it directly0descendants
- K080481Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin CalibratorsBeckman Coulter, Inc. · 2009 · cites it directly0descendants
- K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000196 | Access Myoglobin on the Access Immunoassay Analyzer, Models 33310, 33315… | Beckman Coulter, Inc. | 2000 | — |
| 0 (this device) | K021229 | Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model… | Beckman Coulter, Inc. | 2002 | — |
| +1 | K231832 | Access Myoglobin | Beckman Coulter, Inc. | 2023 | — |
| +1 | K080481 | Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin… | Beckman Coulter, Inc. | 2009 | — |
| +1 | K062737 | Cardiac Markers on Abx Pentra 400 Clinical Chemistry Analyzer | Horiba Abx | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2023 | 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 DDR? 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 DDR device
- #1 K231832 Access Myoglobinscore 6.3 · 2 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 |
|---|---|---|---|
| * | K000196 | Access Myoglobin on the Access Immunoassay Analyzer, Models 33310, 33315, 33319, 33316 | 2000 |
What descends from it? (3)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2007 | Not classified | Z-1396-2009 | Labeling False and Misleading | Beckman Coulter initiated the field action as a result of recent internal testing following the CLSI EP-5A - Evaluation of Precision Performance of Clinical Chemistry Devices protocol, it was determined that the total imprecision for the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DDR devicesDDR Myoglobin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DDR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DDR
Too few DDR 510(k)s in any year since 2007 to give a median.
Recalls per year · DDR
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DDR
5in 2025
MAUDE reports naming product code DDR, 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 | — | 2 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 2 | 0 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 31 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021229 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021229: Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243, 973244.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021229
Report an extraction error
Are you the manufacturer?
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