510(k) Report

FDA applicant

Gebauer Co.

Cleveland, OH11 decisions1994–20269 recalls

FDA records 11 decisions for Gebauer Co. (Cleveland, OH) from 1994 to 2026: 11 510(k) clearances. Most are in product codes MLY (Vapocoolant Device) and LFD (Saliva, Artificial). Its devices cite 9 predicates, 8 of them its own earlier devices. 9 recalls are linked to its devices.

FDA’s records also spell it “Gebauer Company”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Gebauer Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2017: 12019: 12026 (partial year): 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2008

2007: 72008: 1
2007high 7 (2007) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Gebauer Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gebauer Co.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MLYVapocoolant Device10decisions
  • LFDSaliva, Artificial1decision

Whose devices does it build on?

Its devices cite 9 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 24 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K981693Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25Gebauer Co. · 20018cite it
  • K032671Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray), Models P/N 0386-0010-07Gebauer Co. · 20044cite it
  • K021726Gebauer's Instant IceGebauer Co. · 20024cite it
  • K991514Gebauer's Chloride Fine NozzeGebauer Co. · 19993cite it
  • K172028Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company · 20173cite it
  • K031036Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin Refrigerent (Medium Spray)…Gebauer Co. · 20032cite it

What has FDA decided for it lately?

  • K260870Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company · 2026
  • K190161Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride…Gebauer Company · 2019
  • K172028Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company · 2017
  • K032671Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray), Models P/N 0386-0010-07Gebauer Co. · 20043 recalls
  • K031036Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin Refrigerent (Medium Spray)…Gebauer Co. · 20031 recall
  • K021726Gebauer's Instant IceGebauer Co. · 20022 recalls
  • K981693Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25Gebauer Co. · 20012 recalls
  • K002596Gebauer's Fluro Ethyl, Model 0386-0002-09Gebauer Co. · 20011 recall

All 8 as Gebauer Co. →All 3 as Gebauer Company →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K002596Gebauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N…Sep 3, 2008
  • K031036Gebauer''s Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is…Apr 17, 2007
  • K032671Gebauer''s Pain Ease Mist Spray- Topical Anesthetic Skin Refrigerant -is a vapocoolant…Apr 17, 2007
  • K021726Gebauer''s Instant Ice Mist- is used like ice for the temporary relief and reduction of…Apr 17, 2007
  • K021726Gebauer''s Instant Ice Medium Stream - temporary relief and reduction of minor pain and…Apr 17, 2007
  • K032671Gebauer''s Pain Ease Medium Stream -Topical Anesthetic Skin Refrigerant is a vapocoolant…Apr 17, 2007

Other applicant names beginning “Gebauer”

FDA records each applicant name separately; these may or may not be the same firm.

Gebauer Medizintechnik GmbH 2