510(k) · Cleared
ClearedVapocoolshot Mist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vapocoolshot, Inc. · MLY Vapocoolant Device
Cleared on Apr 14, 2020 as substantially equivalent to K172028 (Gebauer Company, 2017) and 1 other predicate after a 133-day review. Its family tree reaches back 5 generations to 1999. 1 later device descends from it.
- Decided
- Apr 14, 2020
- Review
- 133 days
- Class
- Class U
- Product code
- MLY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K991514 (1999). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK991514 Gebauer's Chloride Fine NozzeGebauer Co. · 1999
- 4 generations backK021726 Gebauer's Instant IceGebauer Co. · 2002 · Recalled
- 3 generations backK031036 Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07…Gebauer Co. · 2003 · Recalled
- 2 generations backK032671 Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant…Gebauer Co. · 2004 · Recalled
- 1 generation backK172028 Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray…Gebauer Company · 2017
- This deviceK193349 Vapocoolshot MistVapocoolshot, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK201248 Syringe Holder accessoryVapocoolshot, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201248Syringe Holder accessoryVapocoolshot, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K991514 | Gebauer's Chloride Fine Nozze | Gebauer Co. | 1999 | — |
| −4 | K021726 | Gebauer's Instant Ice | Gebauer Co. | 2002 | 2 |
| −3 | K031036 | Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's… | Gebauer Co. | 2003 | 1 |
| −2 | K032671 | Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream… | Gebauer Co. | 2004 | 3 |
| −1 | K172028 | Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium… | Gebauer Company | 2017 | — |
| 0 (this device) | K193349 | Vapocoolshot Mist | Vapocoolshot, Inc. | 2020 | — |
| +1 | K201248 | Syringe Holder accessory | Vapocoolshot, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
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 |
|---|---|---|---|
| * | K172028 | Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Summary page 4…dicate Device: Gebauer’s Pain Ease (Mist Spray & Stream Spray) Gebauer Company. K172028 Legally marketed medical device 3. Predicate 1: Ouchless… | 2017 |
| * | K093951 | Ouchless Model PN10114Summary page 4…arketed medical device 3. Predicate 1: Ouchless Occam Design LLC K093951 Page 1 of 6 Vapocoolshot Mist - Traditio… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201248 | Syringe Holder accessory | 2020 | 0 |
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 21 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K201248 (Vapocoolshot, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K172028.
How does its category compare?
All MLY devicesMLY Vapocoolant Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Vapocoolshot Mist is intended for topical application to skin, intact mucous membrane (oral cavity, nasal passageways, lips) and minor open wounds. The Vapocoolshot Mist is used to target and minimize cooling area for lessening pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical procedures (such as lancing boils, incision, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts, and abrasions).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193349 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193349: Vapocoolshot Mist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193349
Report an extraction error
Are you the manufacturer?
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