510(k) · Cleared
ClearedEthyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gebauer Company · MLY Vapocoolant Device
Cleared on May 7, 2019 as substantially equivalent to K991514 (Gebauer Co., 1999) and 1 other predicate after a 97-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- May 7, 2019
- Review
- 97 days
- Class
- Class U
- Product code
- MLY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K991514 (1999). No later device cites it as a predicate yet.
- Root · 4 generations backK991514 Gebauer's Chloride Fine NozzeGebauer Co. · 1999
- 3 generations backK021726 Gebauer's Instant IceGebauer Co. · 2002 · Recalled
- 2 generations backK031036 Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07…Gebauer Co. · 2003 · Recalled
- 1 generation backK032671 Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant…Gebauer Co. · 2004 · Recalled
- This deviceK190161 Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint…Gebauer Company · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K991514 | Gebauer's Chloride Fine Nozze | Gebauer Co. | 1999 | — |
| −3 | K021726 | Gebauer's Instant Ice | Gebauer Co. | 2002 | 2 |
| −2 | K031036 | Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's… | Gebauer Co. | 2003 | 1 |
| −1 | K032671 | Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream… | Gebauer Co. | 2004 | 3 |
| 0 (this device) | K190161 | Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl… | Gebauer Company | 2019 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991514 | Gebauer's Chloride Fine NozzeSummary page 4…imary: Gebauer’s Ethyl Chloride (Fine Spray and Medium Spray) K991514 Legally marketed medical device Secondary: Gebauer’s P… | 1999 |
| * | K032671 | Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray)…Summary page 5…510(k) No. K190161 Ethyl Chloride – Traditional 510(k) Document K032671 IV. DESCRIPTION Gebauer’s Ethyl Chloride Topical Anesthetic Spray is a prescription device designed to deli… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 2 other devices also cite its predicate K991514.
How does its category compare?
All MLY devicesMLY Vapocoolant Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Gebauer's Ethyl Chloride Topical Anesthetic Spray (Mist Spray, Fine Spray and Medium Spray): A vapocoolant (skin refrigerant) intended for topical application to control pain associated with injections (starting IV's and venipuncture), minor surgical procedures (such as lancing boils, or incision and drainage of small abscesses), and the temporary relief of minor sports injuries. The Fine and Medium Sprays are also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190161: Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190161
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026