510(k) · Cleared
ClearedHemagen Cardiolipin Antibody Kit (Eia METHOD0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemagen Diagnostics, Inc. · MID System, Test, Anticardiolipin Immunological
Cleared on Jul 16, 1993 after a 60-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jul 16, 1993
- Review
- 60 days
- Class
- Class II
- Product code
- MID
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK932373 Hemagen Cardiolipin Antibody Kit (Eia METHOD0Hemagen Diagnostics, Inc. · 1993
- Descendant · cites it directly · 0 of its ownK992241 Virgo B2 Glycoprotein I Iga Antibody KitHemagen Diagnostics, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK992243 Virgo Beta 2 Glycoprotein Igm Antibody KitHemagen Diagnostics, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK992224 Virgo Beta 2 Glycoprotein Igg Antibody KitHemagen Diagnostics, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK971039 Hemagen Anti Cardiolipin ScreenHemagen Diagnostics, Inc. · 1997
Most influential descendants
Showing 4 of 4 · See all- K992241Virgo B2 Glycoprotein I Iga Antibody KitHemagen Diagnostics, Inc. · 1999 · cites it directly0descendants
- K992243Virgo Beta 2 Glycoprotein Igm Antibody KitHemagen Diagnostics, Inc. · 1999 · cites it directly0descendants
- K992224Virgo Beta 2 Glycoprotein Igg Antibody KitHemagen Diagnostics, Inc. · 1999 · cites it directly0descendants
- K971039Hemagen Anti Cardiolipin ScreenHemagen Diagnostics, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932373 | Hemagen Cardiolipin Antibody Kit (Eia METHOD0 | Hemagen Diagnostics, Inc. | 1993 | — |
| +1 | K992241 | Virgo B2 Glycoprotein I Iga Antibody Kit | Hemagen Diagnostics, Inc. | 1999 | — |
| +1 | K992243 | Virgo Beta 2 Glycoprotein Igm Antibody Kit | Hemagen Diagnostics, Inc. | 1999 | — |
| +1 | K992224 | Virgo Beta 2 Glycoprotein Igg Antibody Kit | Hemagen Diagnostics, Inc. | 1999 | — |
| +1 | K971039 | Hemagen Anti Cardiolipin Screen | Hemagen Diagnostics, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 3 | 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 MID? 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 MID device
- #1 K223093 Aptiva APS IgG Reagent; Aptiva APS IgM Reagentscore 8.8 · 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? (4)
4 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, K992241 (Hemagen Diagnostics, Inc., 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MID devicesMID System, Test, Anticardiolipin Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MID
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MID
234in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MID
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MID
1in 2023
MAUDE reports naming product code MID, 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 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 234 | 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 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K932373 · printed Nov 4, 2026
Cite this page
510(k) Report. “K932373: Hemagen Cardiolipin Antibody Kit (Eia METHOD0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K932373
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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