510(k) · Cleared
Recalled · 2008Ethyl Alcohol Clinical Standard Solutions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emd Chemicals, Inc. · DNN Calibrators, Ethyl Alcohol
Cleared on Mar 31, 1999 after a 41-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 3 times.
- Decided
- Mar 31, 1999
- Review
- 41 days
- Class
- Class II
- Product code
- DNN
- Recalls
- 3
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DNN? 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’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|---|
| Mar 27, 2008 | Not classified | Z-1607-2008 | Process control | Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard. |
| Dec 13, 2002 | Not classified | Z-0684-03 | Other | The Ethanol Standard is OOS on the low end. The results were 0.44 mg/mL while the specification is 0.48-0.52 mg/mL. |
| Dec 13, 2002 | Not classified | Z-0683-03 | Other | The Ethanol Standard is OOS on the high end. The results were 1.58 mg/mL while the specification is 1.477-1.538 mg/mL. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All DNN devicesDNN Calibrators, Ethyl Alcohol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DNN
FDA has decided no DNN device since 2007.
Median 510(k) review, days · DNN
Too few DNN 510(k)s in any year since 2007 to give a median.
Recalls per year · DNN
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DNN
No MAUDE report names DNN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 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 | — |
What is it indicated for?
The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization of instruments and methods for the determination of Ethyl alcohol in whole blood or serum. The Standard Solutions may also be used for validation of the laboratory's routine standards and/or control materials.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990516 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990516: Ethyl Alcohol Clinical Standard Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990516
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026