510(k) · Cleared
Recalled · 2007Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin Refrigerent (Medium Spray), Model P/N-03
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gebauer Co. · MLY Vapocoolant Device
Cleared on Jul 10, 2003 as substantially equivalent to K991514 (Gebauer Co., 1999) and 1 other predicate after a 100-day review. Its family tree reaches back 2 generations to 1999. 11 later devices descend from it. It has been recalled once.
- Decided
- Jul 10, 2003
- Review
- 100 days
- Class
- Class U
- Product code
- MLY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K991514 (1999). 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK991514 Gebauer's Chloride Fine NozzeGebauer Co. · 1999
- 1 generation backK021726 Gebauer's Instant IceGebauer Co. · 2002 · Recalled
- This deviceK031036 Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07…Gebauer Co. · 2003
- Descendant · cites it directly · 9 of its ownK032671 Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant…Gebauer Co. · 2004 · Recalled
- Descendant · 2 generations on · 4 of its ownK172028 Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray…Gebauer Company · 2017
- Descendant · 2 generations on · 3 of its ownK162218 Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist…Nuance Medical, LLC · 2016
- Descendant · 3 generations on · 1 of its ownK232674 PainFreeze IINuance Medical, LLC · 2024
- Descendant · 3 generations on · 1 of its ownK193349 Vapocoolshot MistVapocoolshot, Inc. · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K032671Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray)…Gebauer Co. · 2004 · cites it directly9descendants
- K172028Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company · 2017 · 2 generations on4descendants
- K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102Nuance Medical, LLC · 2016 · 2 generations on3descendants
- K232674PainFreeze IINuance Medical, LLC · 2024 · 3 generations on1descendant
- K193349Vapocoolshot MistVapocoolshot, Inc. · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991514 | Gebauer's Chloride Fine Nozze | Gebauer Co. | 1999 | — |
| −1 | K021726 | Gebauer's Instant Ice | Gebauer Co. | 2002 | 2 |
| 0 (this device) | K031036 | Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's… | Gebauer Co. | 2003 | — |
| +1 | K032671 | Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream… | Gebauer Co. | 2004 | 3 |
| +2 | K172028 | Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium… | Gebauer Company | 2017 | — |
| +2 | K162218 | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray… | Nuance Medical, LLC | 2016 | — |
| +3 | K232674 | PainFreeze II | Nuance Medical, LLC | 2024 | — |
| +3 | K193349 | Vapocoolshot Mist | Vapocoolshot, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K991514 | Gebauer's Chloride Fine NozzeSummary page 1…Spray and Medium Spray)l, to be sold as a prescription product, which we claim is substantially equivalent to Gebauer’s Ethyl Chloride@(Fine and Medium Nozzles) 5 1O(k) K9915 14 and Gebauer’s Instant ICE (Mist and Stream Spray) 5 1O(k) KO2 1726. Description: Gebauer’s Skin Refrigerant (Mist and Medium Spr… | 1999 |
| * | K021726 | Gebauer's Instant Ice | 2002 |
What descends from it? (11)
See all 112 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 17, 2007 | Not classified | Z-1058-2007 | Other | Mold contamination |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K032671 (Gebauer Co., 2004) has gone furthest, with 9 descendants of its own.
- 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.
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 Skin Refrigerant (Mist Spray and Medium Spray) Topical Anesthetic: a vapocoolant (skin refrigerant) intended for topical application to control pain associated with minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses), injections (venipuncture, IV starts) and the temporary relief of minor sports injuries. The Medium Spray is also intended for the treatment of restricted motion associated with myofascial pain caused by trigger points.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031036: Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin Refrigerent (Medium Spray), Model P/N-03.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031036
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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