# Gebauer Co.

- Location (FDA's records): Cleveland, OH
- FDA decisions: 11 (1994–2026): 11 510(k) clearances
- Names in FDA's records: Gebauer Co. (8); Gebauer Company (3)
- Product codes: MLY (10), LFD (1)
- Predicates its devices cite: 9 (8 its own); citations of its devices by later devices: 24 (8 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nuance Medical, LLC: 1 (https://510kreport.com/company/nuance-medical)

## Firms that cite its devices most
- Sinclair Pharmaceuticals, Ltd.: 2 (https://510kreport.com/company/sinclair-pharmaceuticals)
- Nuance Medical, LLC: 2 (https://510kreport.com/company/nuance-medical)
- Parnell Pharmaceuticals, Inc.: 1 (https://510kreport.com/company/parnell-pharmaceuticals)
- Vapocoolshot, Inc.: 1 (https://510kreport.com/company/vapocoolshot)
- Itw Contamination Control Electronics: 1 (https://510kreport.com/company/itw-contamination-control-electronics)
- 623 Medical, LLC: 1 (https://510kreport.com/company/623-medical)
- Glaxosmithkline Consumer Healthcare: 1 (https://510kreport.com/company/glaxosmithkline-consumer-healthcare)
- Laboratoires Carilene S.A.S.: 1 (https://510kreport.com/company/laboratoires-carilene)

## Its most-cited devices
- K981693: Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25 (2001), cited by 8
- 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
- K991514: Gebauer's Chloride Fine Nozze (1999), cited by 3
- K172028: Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) (2017), cited by 3
- 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

## Recent decisions
- K260870: Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) (Aug 27, 2026)
- K190161: Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray (May 7, 2019)
- K172028: Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) (Oct 27, 2017)
- K032671: Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray), Models P/N 0386-0010-07 (Mar 17, 2004)
- K031036: Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin Refrigerent (Medium Spray), Model P/N-03 (Jul 10, 2003)
- K021726: Gebauer's Instant Ice (Dec 12, 2002)
- K981693: Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25 (Aug 6, 2001)
- K002596: Gebauer's Fluro Ethyl, Model 0386-0002-09 (Feb 15, 2001)

Source page: https://510kreport.com/company/gebauer