510(k) · Cleared
ClearedTDX Digitoxin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LFM Enzyme Immunoassay, Digitoxin
Cleared on Aug 16, 1984 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Aug 16, 1984
- Review
- 69 days
- Class
- Class II
- Product code
- LFM
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK842280 TDX DigitoxinAbbott Laboratories · 1984
- Descendant · cites it directly · 17 of its ownK972250 Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 9 of its ownK980996 Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK…Roche Diagnostic Systems, Inc. · 1998
- Descendant · 3 generations on · 8 of its ownK031879 Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp. · 2003
- Descendant · 4 generations on · 2 of its ownK032377 Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp. · 2003
- Descendant · 4 generations on · 1 of its ownK183555 GEM Premier ChemSTATInstrumentation Laboratory CO · 2019
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K972250Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1997 · cites it directly17descendants
- K980996Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf)Roche Diagnostic Systems, Inc. · 1998 · 2 generations on9descendants
- K031879Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp. · 2003 · 3 generations on8descendants
- K032377Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp. · 2003 · 4 generations on2descendants
- K183555GEM Premier ChemSTATInstrumentation Laboratory CO · 2019 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K842280 | TDX Digitoxin | Abbott Laboratories | 1984 | — |
| +1 | K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | 1997 | 1 |
| +2 | K980996 | Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf) | Roche Diagnostic Systems, Inc. | 1998 | — |
| +3 | K031879 | Cobas Integra Carbon Dioxide Assay | Roche Diagnostics Corp. | 2003 | — |
| +4 | K032377 | Roche Diagnostics Hitachi Bicarbonate Liquid | Roche Diagnostics Corp. | 2003 | — |
| +4 | K183555 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2019 | 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 LFM? 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? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary Reagents | 1997 | 17 |
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, K972250 (Roche Diagnostic Systems, Inc., 1997) has gone furthest, with 17 descendants of its own.
How does its category compare?
All LFM devicesLFM Enzyme Immunoassay, Digitoxin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFM
FDA has decided no LFM device since 2007.
Median 510(k) review, days · LFM
Too few LFM 510(k)s in any year since 2007 to give a median.
Recalls per year · LFM
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFM
18in 2025
MAUDE reports naming product code LFM, 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 3 |
| 2013 | 0 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 29 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 27 |
| 2024 | 0 | — | 2 | 1 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K842280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K842280: TDX Digitoxin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K842280
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026