510(k) · Cleared
ClearedTDX Procainamide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LAR Enzyme Immunoassay, Procainamide
Cleared on Feb 3, 1984 after a 45-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
- Feb 3, 1984
- Review
- 45 days
- Class
- Class II
- Product code
- LAR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK834464 TDX ProcainamideAbbott Laboratories · 1984
- Descendant · cites it directly · 1 of its ownK962269 Cedia Cardiac TDM Multi-CalsBoehringer Mannheim Corp. · 1996
- Descendant · 2 generations on · 0 of its ownK972433 Cedia Digoxin CalibratorsBoehringer Mannheim Corp. · 1997
- Descendant · cites it directly · 0 of its ownK962099 Cedia Procainamide AssayBoehringer Mannheim Corp. · 1996
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K834464 | TDX Procainamide | Abbott Laboratories | 1984 | — |
| +1 | K962269 | Cedia Cardiac TDM Multi-Cals | Boehringer Mannheim Corp. | 1996 | — |
| +2 | K972433 | Cedia Digoxin Calibrators | Boehringer Mannheim Corp. | 1997 | — |
| +1 | K962099 | Cedia Procainamide Assay | Boehringer Mannheim Corp. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 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 LAR? 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)
2 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, K962269 (Boehringer Mannheim Corp., 1996) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LAR devicesLAR Enzyme Immunoassay, Procainamide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LAR
FDA has decided no LAR device since 2007.
Median 510(k) review, days · LAR
Too few LAR 510(k)s in any year since 2007 to give a median.
Recalls per year · LAR
No recall names LAR since 2007.
Adverse event reports per year · LAR
No MAUDE report names LAR 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 | 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 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K834464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K834464: TDX Procainamide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K834464
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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