510(k) · Cleared
ClearedCedia Digoxin Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · DLJ Calibrators, Drug Specific
Cleared on Jul 24, 1997 as substantially equivalent to K962269 (Boehringer Mannheim Corp., 1996) after a 24-day review. Its family tree reaches back 2 generations to 1983.
- Decided
- Jul 24, 1997
- Review
- 24 days
- Class
- Class II
- Product code
- DLJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K830206 (1983). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830206 | TDX N-Acetylprocainamide | Abbott Laboratories | 1983 | — |
| −1 | K962269 | Cedia Cardiac TDM Multi-Cals | Boehringer Mannheim Corp. | 1996 | — |
| 0 (this device) | K972433 | Cedia Digoxin Calibrators | Boehringer Mannheim Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DLJ? 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962269 | Cedia Cardiac TDM Multi-CalsSummary page 1…lassification name: Calibrators, drug mixture The Boehringer Mannheim CEDIA Digoxin Calibrators are substantially equivalent to the CEDIA Cardiac TDM Multi-Calibrators (K962269). The CEDIA Digoxin Calibrators are manufactured using bovine serum albumin, digoxin, stabilizers, and preservatives. The drug i… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 13.7 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All DLJ devicesDLJ Calibrators, Drug Specific: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DLJ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · DLJ
Too few DLJ 510(k)s in any year since 2007 to give a median.
Recalls per year · DLJ
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DLJ
3in 2025
MAUDE reports naming product code DLJ, 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 2 | 6 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CEDIA Digoxin Calibrators are used to calibrate the CEDIA Digoxin II assay on the Synchron.
The CEDIA Digoxin Calibrators are used to determine drug concentrations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972433: Cedia Digoxin Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972433
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026