# K031036: Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin Refrigerent (Medium Spray), Model P/N-03

- Pathway: 510(k) (Traditional)
- Applicant: Gebauer Co.
- Decided: Jul 10, 2003 after 100 days
- Product code: MLY (Vapocoolant Device)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991514 (1999). 2 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991514: Gebauer's Chloride Fine Nozze, Gebauer Co. (1999) Summary page 1.
- K021726: Gebauer's Instant Ice, Gebauer Co. (2002)

## Most influential descendants
- K032671: Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray), Models P/N 0386-0010-07 (2004), 9 descendants of its own
- K172028: Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) (2017), 4 descendants of its own
- K162218: Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 (2016), 3 descendants of its own
- K232674: PainFreeze II (2024), 1 descendant of its own
- K193349: Vapocoolshot Mist (2020), 1 descendant of its own

## Recalls of this device
- Apr 17, 2007 · Not classified · Z-1058-2007: Mold contamination

## Indications for use
Gebauer’s Skin Refrigerant (Mist Spray and Medium Spray) Topical Anesthetic: a vapocoolant (skin refrigerant) intended for topical application to control pain associated with minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses), injections (venipuncture, IV starts) and the temporary relief of minor sports injuries. The Medium Spray is also intended for the treatment of restricted motion associated with myofascial pain caused by trigger points.

Source page: https://510kreport.com/device/K031036
Methodology: https://510kreport.com/methodology