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 Oct 27, 2017 as substantially equivalent to K032671 (Gebauer Co., 2004) after a 114-day review. Its family tree reaches back 4 generations to 1999. 4 later devices descend from it.
- Decided
- Oct 27, 2017
- Review
- 114 days
- Class
- Class U
- Product code
- MLY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K991514 (1999). 4 later devices descend from it, 3 citing it directly.
- 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 deviceK172028 Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray…Gebauer Company · 2017
- Descendant · cites it directly · 1 of its ownK193349 Vapocoolshot MistVapocoolshot, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK261684 FreezeSpray TACryosurgery, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK260870 Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray…Gebauer Company · 2026
- Descendant · 2 generations on · 0 of its ownK201248 Syringe Holder accessoryVapocoolshot, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K193349Vapocoolshot MistVapocoolshot, Inc. · 2020 · cites it directly1descendant
- K261684FreezeSpray TACryosurgery, Inc. · 2026 · cites it directly0descendants
- K260870Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company · 2026 · cites it directly0descendants
- K201248Syringe Holder accessoryVapocoolshot, Inc. · 2020 · 2 generations on0descendants
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) | K172028 | Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium… | Gebauer Company | 2017 | — |
| +1 | K193349 | Vapocoolshot Mist | Vapocoolshot, Inc. | 2020 | — |
| +1 | K261684 | FreezeSpray TA | Cryosurgery, Inc. | 2026 | — |
| +1 | K260870 | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium… | Gebauer Company | 2026 | — |
| +2 | K201248 | Syringe Holder accessory | Vapocoolshot, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K032671 | Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray)…Summary page 4…Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) Cold Spray Refrigerant Topical, Vapocoolant MLY o rrinrary. Gebauer’s Pain B Medium Spray K032671 Legally marketed medical device 510(k) No. K1720238 Pain Ease — Traditional 510(k) Document IV. DESCRIPTION G… | 2004 |
What descends from it? (4)
3 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)
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 18 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.
- Of its descendants, K193349 (Vapocoolshot, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K032671.
How does its category compare?
All MLY devicesMLY Vapocoolant Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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, mucous membranes 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 the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). The Medium Spray is also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172028: 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/K172028
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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