510(k) · Cleared
Recalled · 2007Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray), Models P/N 0386-0010-07
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gebauer Co. · MLY Vapocoolant Device
Cleared on Mar 17, 2004 as substantially equivalent to K031036 (Gebauer Co., 2003) after a 201-day review. Its family tree reaches back 3 generations to 1999. 9 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 17, 2004
- Review
- 201 days
- Class
- Class U
- Product code
- MLY
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K991514 (1999). 9 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK991514 Gebauer's Chloride Fine NozzeGebauer Co. · 1999
- 2 generations backK021726 Gebauer's Instant IceGebauer Co. · 2002 · Recalled
- 1 generation backK031036 Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07…Gebauer Co. · 2003 · Recalled
- This deviceK032671 Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant…Gebauer Co. · 2004
- Descendant · cites it directly · 4 of its ownK172028 Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray…Gebauer Company · 2017
- Descendant · cites it directly · 3 of its ownK162218 Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist…Nuance Medical, LLC · 2016
- Descendant · 2 generations on · 1 of its ownK232674 PainFreeze IINuance Medical, LLC · 2024
- Descendant · 2 generations on · 1 of its ownK193349 Vapocoolshot MistVapocoolshot, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK261684 FreezeSpray TACryosurgery, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K172028Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company · 2017 · cites it directly4descendants
- K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102Nuance Medical, LLC · 2016 · cites it directly3descendants
- K232674PainFreeze IINuance Medical, LLC · 2024 · 2 generations on1descendant
- K193349Vapocoolshot MistVapocoolshot, Inc. · 2020 · 2 generations on1descendant
- K261684FreezeSpray TACryosurgery, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991514 | Gebauer's Chloride Fine Nozze | Gebauer Co. | 1999 | — |
| −2 | K021726 | Gebauer's Instant Ice | Gebauer Co. | 2002 | 2 |
| −1 | K031036 | Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's… | Gebauer Co. | 2003 | 1 |
| 0 (this device) | K032671 | Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream… | Gebauer Co. | 2004 | — |
| +1 | K172028 | Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium… | Gebauer Company | 2017 | — |
| +1 | K162218 | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray… | Nuance Medical, LLC | 2016 | — |
| +2 | K232674 | PainFreeze II | Nuance Medical, LLC | 2024 | — |
| +2 | K193349 | Vapocoolshot Mist | Vapocoolshot, Inc. | 2020 | — |
| +2 | K261684 | FreezeSpray TA | Cryosurgery, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 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? (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 |
|---|---|---|---|
| * | K031036 | Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin…Summary page 1…271-5252, ext. 20 Fax: (216) 271-5335 Predicate Device: Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) 510(k) K031036 Description: Gebauer's Skin Refrigerant (Mist and Medium Spray) Topical Anesthetic is a prescription device designed to deliver… | 2003 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172028 | Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | 2017 | 4 |
| K162218 | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 | 2016 | 3 |
| K190161 | Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride… | 2019 | 0 |
| K172598 | Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream… | 2018 | 0 |
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-1057-2007 | Other | Mold contamination |
| Apr 17, 2007 | Not classified | Z-1061-2007 | Other | Mold contamination |
| Apr 17, 2007 | Not classified | Z-1062-2007 | Other | Mold contamination |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 8 months on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K172028 (Gebauer Company, 2017) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K031036.
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 skin, intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds. Gebauer's Skin Refrigerant 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 as stated in the FDA summary.
https://510kreport.com/device/K032671 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032671: Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray), Models P/N 0386-0010-07.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032671
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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