510(k) · Cleared
ClearedAccess Myoglobin on the Access Immunoassay Analyzer, Models 33310, 33315, 33319, 33316
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 Feb 18, 2000 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 18, 2000
- Review
- 28 days
- Class
- Class II
- Product code
- DDR
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK000196 Access Myoglobin on the Access Immunoassay Analyzer, Models 33310…Beckman Coulter, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK021229 Myoglobin and Myoglobin Calibrators on the Access Immunoassay…Beckman Coulter, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 0 of its ownK231832 Access MyoglobinBeckman Coulter, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK080481 Access Immunoassay Systems Myoglobin and Access Immunoassay Systems…Beckman Coulter, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK062737 Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2007
- Descendant · cites it directly · 0 of its ownK012040 Ramp Myoglobin AssayResponse Biomedical Corp. · 2001
Most influential descendants
Showing 5 of 5 · See all- K021229Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243…Beckman Coulter, Inc. · 2002 · cites it directly3descendants
- K231832Access MyoglobinBeckman Coulter, Inc. · 2023 · 2 generations on0descendants
- K080481Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin CalibratorsBeckman Coulter, Inc. · 2009 · 2 generations on0descendants
- K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2007 · 2 generations on0descendants
- K012040Ramp Myoglobin AssayResponse Biomedical Corp. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000196 | Access Myoglobin on the Access Immunoassay Analyzer, Models 33310, 33315… | Beckman Coulter, Inc. | 2000 | — |
| +1 | K021229 | Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model… | Beckman Coulter, Inc. | 2002 | 1 |
| +2 | K231832 | Access Myoglobin | Beckman Coulter, Inc. | 2023 | — |
| +2 | K080481 | Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin… | Beckman Coulter, Inc. | 2009 | — |
| +2 | K062737 | Cardiac Markers on Abx Pentra 400 Clinical Chemistry Analyzer | Horiba Abx | 2007 | — |
| +1 | K012040 | Ramp Myoglobin Assay | Response Biomedical Corp. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K021229 (Beckman Coulter, Inc., 2002) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K000196 · printed Nov 5, 2026
Cite this page
510(k) Report. “K000196: Access Myoglobin on the Access Immunoassay Analyzer, Models 33310, 33315, 33319, 33316.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000196
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026