510(k) · Cleared
Recalled · 2003Axsym Tricyclic Antidepressants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs
Cleared on Nov 22, 1995 after a 103-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 2 times.
- Decided
- Nov 22, 1995
- Review
- 103 days
- Class
- Class II
- Product code
- LFH
- Recalls
- 2
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 LFH? 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 LFH device
- #1 K213875 DRI TM Tricyclics Serum Tox Assayscore 7.5 · 1 generation · no Class I recall
- #2 Held for the reportin 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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 17, 2003 | Not classified | Z-0323-04 | Other | Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay. |
| Dec 11, 2002 | Not classified | Z-0689-03 | Other | Unexpected false positive TCA results |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LFH devicesLFH U.V. Spectrometry, Tricyclic Antidepressant Drugs: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFH
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LFH
Too few LFH 510(k)s in any year since 2007 to give a median.
Recalls per year · LFH
No recall names LFH since 2007.
Adverse event reports per year · LFH
1in 2007
MAUDE reports naming product code LFH, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 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 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K953761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953761: Axsym Tricyclic Antidepressants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953761
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026