510(k) · Cleared
ClearedPain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuance Medical, LLC · MLY Vapocoolant Device
Cleared on Nov 22, 2016 as substantially equivalent to K032671 (Gebauer Co., 2004) after a 106-day review. Its family tree reaches back 4 generations to 1999. 3 later devices descend from it.
- Decided
- Nov 22, 2016
- Review
- 106 days
- Class
- Class U
- Product code
- MLY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K991514 (1999). 3 later devices descend from it, 2 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 deviceK162218 Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist…Nuance Medical, LLC · 2016
- Descendant · cites it directly · 1 of its ownK232674 PainFreeze IINuance Medical, LLC · 2024
- Descendant · cites it directly · 0 of its ownK261684 FreezeSpray TACryosurgery, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260870 Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray…Gebauer Company · 2026
Most influential descendants
Showing 3 of 3 · See allView 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) | K162218 | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray… | Nuance Medical, LLC | 2016 | — |
| +1 | K232674 | PainFreeze II | Nuance Medical, LLC | 2024 | — |
| +1 | K261684 | FreezeSpray TA | Cryosurgery, Inc. | 2026 | — |
| +2 | K260870 | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium… | Gebauer Company | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K032671 | Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray)…Summary page 4…Gebauer’s Pain Ease (Medium Stream Spray & Mist Spray) Gebauer Company. K032671 Legally marketed medical device 510(k) No. K162218… | 2004 |
What descends from it? (3)
2 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 17 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, K232674 (Nuance Medical, LLC, 2024) 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. 2016, 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?
Pain Freeze™ Mist Spray and Medium Stream Spray are vapocoolants (skin refrigerants) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Pain Freeze™ controls pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). Pain Freeze™ Medium Stream Spray is also intended for the management of myofascial pain, restricted motion and muscle tension.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162218 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162218: Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162218
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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