510(k) · Cleared
ClearedSaliva Alcohol Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enzymatics C/O Burditt,Bowles,Radzius & Ruberry · DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Cleared on Apr 5, 1990 after a 304-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 5, 1990
- Review
- 304 days
- Class
- Class II
- Product code
- DIC
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK894001 Saliva Alcohol TestEnzymatics C/O Burditt,Bowles,Radzius & Ruberry · 1990
- Descendant · cites it directly · 2 of its ownK093879 Mission Saliva Alcohol Test StripACON Laboratories, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK121256 Alco-Screen 02Chematics, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK250609 Sober Self-TestSober Ip, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK121247 Alco-ScreenChematics, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK111206 Teco Diagnostics Saliva Alcohol TestTeco Diagnostics · 2011
Most influential descendants
Showing 5 of 5 · See all- K093879Mission Saliva Alcohol Test StripACON Laboratories, Inc. · 2010 · cites it directly2descendants
- K121256Alco-Screen 02Chematics, Inc. · 2012 · cites it directly1descendant
- K250609Sober Self-TestSober Ip, LLC · 2025 · 2 generations on0descendants
- K121247Alco-ScreenChematics, Inc. · 2013 · 2 generations on0descendants
- K111206Teco Diagnostics Saliva Alcohol TestTeco Diagnostics · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894001 | Saliva Alcohol Test | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | 1990 | — |
| +1 | K093879 | Mission Saliva Alcohol Test Strip | ACON Laboratories, Inc. | 2010 | — |
| +1 | K121256 | Alco-Screen 02 | Chematics, Inc. | 2012 | — |
| +2 | K250609 | Sober Self-Test | Sober Ip, LLC | 2025 | — |
| +2 | K121247 | Alco-Screen | Chematics, Inc. | 2013 | — |
| +2 | K111206 | Teco Diagnostics Saliva Alcohol Test | Teco Diagnostics | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2025 | 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 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? (5)
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, K093879 (ACON Laboratories, Inc., 2010) has gone furthest, with 2 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/K894001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K894001: Saliva Alcohol Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K894001
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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