510(k) · Cleared
ClearedProfile-ER
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtox Diagnostics, Inc. · DIS Enzyme Immunoassay, Barbiturate
Cleared on Jan 17, 2001 after a 169-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jan 17, 2001
- Review
- 169 days
- Class
- Class II
- Product code
- DIS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK002331 Profile-ERMedtox Diagnostics, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK091454 Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK220451 Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited · 2023 · Recalled
- Descendant · 3 generations on · 0 of its ownK250741 Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2026
- Descendant · 2 generations on · 0 of its ownK221550 Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2023
- Descendant · 2 generations on · 0 of its ownK100023 Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test…Medtox Diagnostics, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K091454Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009 · cites it directly4descendants
- K220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited · 2023 · 2 generations on1descendant
- K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2026 · 3 generations on0descendants
- K221550Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2023 · 2 generations on0descendants
- K100023Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test SystemMedtox Diagnostics, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002331 | Profile-ER | Medtox Diagnostics, Inc. | 2001 | — |
| +1 | K091454 | Profile-V Medtoxscan Drugs of Abuse Test System | Medtox Diagnostics, Inc. | 2009 | — |
| +2 | K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | Randox Laboratories Limited | 2023 | 1 |
| +3 | K250741 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | 2026 | — |
| +2 | K221550 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | 2023 | — |
| +2 | K100023 | Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test System | Medtox Diagnostics, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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 DIS? 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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091454 | Profile-V Medtoxscan Drugs of Abuse Test System | 2009 | 4 |
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, K091454 (Medtox Diagnostics, Inc., 2009) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DIS devicesDIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIS
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIS
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIS
1in 2018
MAUDE reports naming product code DIS, 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 | 3 | 331 | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 29 | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 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/K002331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002331: Profile-ER.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002331
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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