510(k) · Cleared
ClearedDupont Dimension (R) Ethyl Alcohol (Alc) Method
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E.I. Dupont DE Nemours & Co., Inc. · DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Cleared on Oct 12, 1990 after a 23-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
- Oct 12, 1990
- Review
- 23 days
- Class
- Class II
- Product code
- DIC
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK904302 Dupont Dimension (R) Ethyl Alcohol (Alc) MethodE.I. Dupont DE Nemours & Co., Inc. · 1990
- Descendant · cites it directly · 0 of its ownK071811 Etoh Flex Reagent Cartridge (DF22)Dade Behring, Inc. · 2007 · Recalled
- Descendant · cites it directly · 0 of its ownK070853 Dimension Vista Etoh Flex Reagent Cartridge, Model K5022Dade Behring, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK061792 Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp)…Dade Behring, Inc. · 2006 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K071811Etoh Flex Reagent Cartridge (DF22)Dade Behring, Inc. · 2007 · cites it directly0descendants
- K070853Dimension Vista Etoh Flex Reagent Cartridge, Model K5022Dade Behring, Inc. · 2007 · cites it directly0descendants
- K061792Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex…Dade Behring, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904302 | Dupont Dimension (R) Ethyl Alcohol (Alc) Method | E.I. Dupont DE Nemours & Co., Inc. | 1990 | — |
| +1 | K071811 | Etoh Flex Reagent Cartridge (DF22) | Dade Behring, Inc. | 2007 | 1 |
| +1 | K070853 | Dimension Vista Etoh Flex Reagent Cartridge, Model K5022 | Dade Behring, Inc. | 2007 | — |
| +1 | K061792 | Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0… | Dade Behring, Inc. | 2006 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 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 DIC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DIC device
- #1 K250609 Sober Self-Testscore 10.3 · 2 generations · no Class I recall
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)
3 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, K071811 (Dade Behring, Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DIC devicesDIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DIC
Too few DIC 510(k)s in any year since 2007 to give a median.
Recalls per year · DIC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIC
3in 2025
MAUDE reports naming product code DIC, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 1 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K904302 · printed Nov 5, 2026
Cite this page
510(k) Report. “K904302: Dupont Dimension (R) Ethyl Alcohol (Alc) Method.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K904302
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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