510(k) · Cleared
ClearedHuman ALPHA2 Macroglobulin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Cleared on Aug 16, 1979 after a 31-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
- Aug 16, 1979
- Review
- 31 days
- Class
- Class II
- Product code
- DEB
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK791340 Human ALPHA2 MacroglobulinBeckman Instruments, Inc. · 1979
- Descendant · cites it directly · 4 of its ownK973932 Beckman Calibrator 2 (CAL2)Beckman Instruments, Inc. · 1997
- Descendant · 2 generations on · 3 of its ownK052819 Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat…Ortho-Clinical Diagnostics, Inc. · 2005
- Descendant · 3 generations on · 1 of its ownK061588 Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 0 of its ownK123930 Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2…Ortho-Clinical Diagnostics, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK060940 Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry…Ortho-Clinical Diagnostics, Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K973932Beckman Calibrator 2 (CAL2)Beckman Instruments, Inc. · 1997 · cites it directly4descendants
- K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · 2 generations on3descendants
- K061588Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy…Ortho-Clinical Diagnostics, Inc. · 2006 · 3 generations on1descendant
- K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2013 · 4 generations on0descendants
- K060940Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT…Ortho-Clinical Diagnostics, Inc. · 2006 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K791340 | Human ALPHA2 Macroglobulin | Beckman Instruments, Inc. | 1979 | — |
| +1 | K973932 | Beckman Calibrator 2 (CAL2) | Beckman Instruments, Inc. | 1997 | — |
| +2 | K052819 | Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance… | Ortho-Clinical Diagnostics, Inc. | 2005 | — |
| +3 | K061588 | Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2006 | 1 |
| +4 | K123930 | Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance… | Ortho-Clinical Diagnostics, Inc. | 2013 | — |
| +3 | K060940 | Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2013 | 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 DEB? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973932 | Beckman Calibrator 2 (CAL2) | 1997 | 4 |
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, K973932 (Beckman Instruments, Inc., 1997) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DEB devicesDEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DEB
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DEB
Too few DEB 510(k)s in any year since 2007 to give a median.
Recalls per year · DEB
No recall names DEB since 2007.
Adverse event reports per year · DEB
No MAUDE report names DEB 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 | 1 | — | 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 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K791340 · printed Nov 4, 2026
Cite this page
510(k) Report. “K791340: Human ALPHA2 Macroglobulin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K791340
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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