510(k) · Cleared
ClearedGebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium 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 Aug 27, 2026 as substantially equivalent to K172028 (Gebauer Company, 2017) and 1 other predicate after a 163-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Aug 27, 2026
- Review
- 163 days
- Class
- Class U
- Product code
- MLY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K991514 (1999). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK991514 Gebauer's Chloride Fine NozzeGebauer Co. · 1999
- 5 generations backK021726 Gebauer's Instant IceGebauer Co. · 2002 · Recalled
- 4 generations backK031036 Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07…Gebauer Co. · 2003 · Recalled
- 3 generations backK032671 Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant…Gebauer Co. · 2004 · Recalled
- 2 generations backK162218 Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist…Nuance Medical, LLC · 2016
- 1 generation backK232674 PainFreeze IINuance Medical, LLC · 2024
- This deviceK260870 Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray…Gebauer Company · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K991514 | Gebauer's Chloride Fine Nozze | Gebauer Co. | 1999 | — |
| −5 | K021726 | Gebauer's Instant Ice | Gebauer Co. | 2002 | 2 |
| −4 | K031036 | Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's… | Gebauer Co. | 2003 | 1 |
| −3 | K032671 | Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream… | Gebauer Co. | 2004 | 3 |
| −2 | K162218 | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray… | Nuance Medical, LLC | 2016 | — |
| −1 | K232674 | PainFreeze II | Nuance Medical, LLC | 2024 | — |
| 0 (this device) | K260870 | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium… | Gebauer Company | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 K261684 FreezeSpray TAscore 13.2 · 5 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 6…n Code Number Date Gebauer’s Pain Vapocoolant Device/Unclassified MLY K172028 10/27/2017 Ease PainFreeze II Vapocoolant Device/Unclassified MLY K232674 2/12/2024 De… | 2017 |
| * | K232674 | PainFreeze IISummary page 6…ain Vapocoolant Device/Unclassified MLY K172028 10/27/2017 Ease PainFreeze II Vapocoolant Device/Unclassified MLY K232674 2/12/2024 Device Description The Subject Device consists of a chemical blend of 90% HFO-1233zd (Trans-1 -chloro- 3,3,3- tr… | 2024 |
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 27 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 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. 2026, 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 Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray): a vapocoolant (skin refrigerant) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Gebauer's Pain Ease controls pain associated with minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses, and sutures), injections (venipuncture, IV starts, cosmetic procedures) and temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260870 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260870: Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260870
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026