# MLY: Vapocoolant Device

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 25
- 510(k) review time 2021–2025: median 185 days (middle half 175–356)
- Recalls: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2010: 1
- 2016: 1
- 2017: 2
- 2018: 1
- 2019: 1
- 2020: 3
- 2022: 1
- 2024: 1
- 2025: 1
- 2026: 2

## Most-cited predicates
- K032671: Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray), Models P/N 0386-0010-07 (2004), cited by 4
- K021726: Gebauer's Instant Ice (2002), cited by 4
- K172028: Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) (2017), cited by 3
- K991514: Gebauer's Chloride Fine Nozze (1999), cited by 3
- K162218: Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 (2016), cited by 2
- K030281: Cryotron 2 Cryotherapy Device (2003), cited by 2
- K093951: Ouchless Model PN10114 (2010), cited by 2
- K031036: Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin Refrigerent (Medium Spray), Model P/N-03 (2003), cited by 2
- K193349: Vapocoolshot Mist (2020), cited by 1
- K232674: PainFreeze II (2024), cited by 1

Source page: https://510kreport.com/product-code/MLY
Data by year (CSV): https://510kreport.com/product-code/MLY.csv