510(k) · Cleared
Recalled · 2008Gebauer's Fluro Ethyl, Model 0386-0002-09
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gebauer Co. · MLY Vapocoolant Device
Cleared on Feb 15, 2001 after a 178-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.
- Decided
- Feb 15, 2001
- Review
- 178 days
- Class
- Class U
- Product code
- MLY
- Recalls
- 1
- Predicates
- 0
FDA has not posted a summary or statement for it, 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 MLY? 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 MLY device
- #1 K260870 Gebauer's Pain Ease Topical Anesthetic Skin…score 13.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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?
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 |
|---|---|---|---|---|
| Sep 3, 2008 | Not classified | Z-0218-2009 | Component design/selection | Some units of Fluro-Ethyl containing the defective valve which could malfunction and spray refrigerant out from the side of the valve in addition to or instead of spraying in the normal inverted position from the product's actuator. The… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MLY devicesMLY Vapocoolant Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MLY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLY
93in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLY
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLY
4in 2025
MAUDE reports naming product code MLY, 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 | 0 | — | 6 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 3 | 93 | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K002596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002596: Gebauer's Fluro Ethyl, Model 0386-0002-09.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002596
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026