510(k) · Cleared
Recalled · Class II · 2013Randox Phenytoin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · DIP Enzyme Immunoassay, Diphenylhydantoin
Cleared on Dec 4, 2001 after a 211-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 2 times.
- Decided
- Dec 4, 2001
- Review
- 211 days
- Class
- Class II
- Product code
- DIP
- Recalls
- 2
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, 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 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 lists a 510(k) statement for it but has not posted the file, 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 |
|---|---|---|---|---|
| Dec 18, 2013 | Class II | Z-0930-2014 | Under Investigation by firm | ADVIA Centaur Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots. |
| Dec 18, 2013 | Class II | Z-0929-2014 | Under Investigation by firm | ADVIA Centaur Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots. |
No ancestor or descendant has a Class I recall.
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/K011393 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011393: Randox Phenytoin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011393
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026