510(k) · Cleared
ClearedAxsym Valproic Acid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LEG Enzyme Immunoassay, Valproic Acid
Cleared on Aug 16, 1994 after a 134-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Aug 16, 1994
- Review
- 134 days
- Class
- Class II
- Product code
- LEG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK941615 Axsym Valproic AcidAbbott Laboratories · 1994
- Descendant · cites it directly · 0 of its ownK090358 Architect Ivalproic Acid Reagents and Architect Ivalproic Acid…Abbott Laboratories, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK030405 QMS / Multigent Valproic Acid Reagent, Part #396075Seradyn · 2003
- Descendant · cites it directly · 0 of its ownK981403 Immage Immunochemistry System Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1998
Most influential descendants
Showing 3 of 3 · See all- K090358Architect Ivalproic Acid Reagents and Architect Ivalproic Acid Calibrators, Models 1P35…Abbott Laboratories, Inc. · 2009 · cites it directly0descendants
- K030405QMS / Multigent Valproic Acid Reagent, Part #396075Seradyn · 2003 · cites it directly0descendants
- K981403Immage Immunochemistry System Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941615 | Axsym Valproic Acid | Abbott Laboratories | 1994 | — |
| +1 | K090358 | Architect Ivalproic Acid Reagents and Architect Ivalproic Acid Calibrators… | Abbott Laboratories, Inc. | 2009 | — |
| +1 | K030405 | QMS / Multigent Valproic Acid Reagent, Part #396075 | Seradyn | 2003 | — |
| +1 | K981403 | Immage Immunochemistry System Valproic Acid (Vpa) Reagent | Beckman Instruments, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 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 LEG? 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? (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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090358 (Abbott Laboratories, Inc., 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LEG devicesLEG Enzyme Immunoassay, Valproic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LEG
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · LEG
Too few LEG 510(k)s in any year since 2007 to give a median.
Recalls per year · LEG
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LEG
5in 2025
MAUDE reports naming product code LEG, 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 | — | 1 | 12 |
| 2008 | 0 | — | 0 | 38 |
| 2009 | 1 | — | 0 | 18 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 1 | 38 |
| 2012 | 0 | — | 0 | 29 |
| 2013 | 0 | — | 0 | 29 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 1 | 24 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K941615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941615: Axsym Valproic Acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941615
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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