510(k) · Cleared
ClearedCedia Phenytoin Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · DIP Enzyme Immunoassay, Diphenylhydantoin
Cleared on Jan 17, 1991 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jan 17, 1991
- Review
- 29 days
- Class
- Class II
- Product code
- DIP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK905689 Cedia Phenytoin AssayMicrogenics Corp. · 1991
- Descendant · cites it directly · 1 of its ownK963840 Cedia Phenytoin II AssayBoehringer Mannheim Corp. · 1996
- Descendant · cites it directly · 1 of its ownK961659 Cedia Core TDM Multi-CalBoehringer Mannheim Corp. · 1996
- Descendant · 2 generations on · 0 of its ownK120936 Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS…Microgenics Corporation · 2012
- Descendant · 2 generations on · 0 of its ownK030428 Roche Online TDM PhenytoinRoche Diagnostics Corp. · 2003 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K963840Cedia Phenytoin II AssayBoehringer Mannheim Corp. · 1996 · cites it directly1descendant
- K961659Cedia Core TDM Multi-CalBoehringer Mannheim Corp. · 1996 · cites it directly1descendant
- K120936Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS Multi-Constituent…Microgenics Corporation · 2012 · 2 generations on0descendants
- K030428Roche Online TDM PhenytoinRoche Diagnostics Corp. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905689 | Cedia Phenytoin Assay | Microgenics Corp. | 1991 | — |
| +1 | K963840 | Cedia Phenytoin II Assay | Boehringer Mannheim Corp. | 1996 | — |
| +1 | K961659 | Cedia Core TDM Multi-Cal | Boehringer Mannheim Corp. | 1996 | — |
| +2 | K120936 | Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS… | Microgenics Corporation | 2012 | — |
| +2 | K030428 | Roche Online TDM Phenytoin | Roche Diagnostics Corp. | 2003 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2003 | 1 | 0 |
| 2012 | 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 DIP? 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? (4)
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, K963840 (Boehringer Mannheim Corp., 1996) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DIP devicesDIP Enzyme Immunoassay, Diphenylhydantoin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIP
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · DIP
Too few DIP 510(k)s in any year since 2007 to give a median.
Recalls per year · DIP
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIP
2in 2025
MAUDE reports naming product code DIP, 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 | 1 | — | 0 | 2 |
| 2008 | 1 | — | 1 | 20 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 59 |
| 2011 | 0 | — | 0 | 104 |
| 2012 | 0 | — | 0 | 51 |
| 2013 | 0 | — | 3 | 163 |
| 2014 | 0 | — | 2 | 57 |
| 2015 | 0 | — | 0 | 65 |
| 2016 | 0 | — | 0 | 69 |
| 2017 | 0 | — | 1 | 55 |
| 2018 | 0 | — | 0 | 79 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 17 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 42 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K905689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K905689: Cedia Phenytoin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905689
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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