510(k) · Cleared
ClearedGebauer's Chloride Fine Nozze
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gebauer Co. · MLY Vapocoolant Device
Cleared on Jul 16, 1999 after a 77-day review. The FDA summary names its predicate without a number. 30 later devices descend from it.
- Decided
- Jul 16, 1999
- Review
- 77 days
- Class
- Class U
- Product code
- MLY
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 3 citing it directly.
- This deviceK991514 Gebauer's Chloride Fine NozzeGebauer Co. · 1999
- Descendant · cites it directly · 29 of its ownK021726 Gebauer's Instant IceGebauer Co. · 2002 · Recalled
- Descendant · 2 generations on · 14 of its ownK030281 Cryotron 2 Cryotherapy DeviceCryonic Medical North America · 2003
- Descendant · 3 generations on · 13 of its ownK170810 CryofosCryofos Medical GmbH · 2017
- Descendant · cites it directly · 11 of its ownK031036 Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07…Gebauer Co. · 2003 · Recalled
- Descendant · 2 generations on · 9 of its ownK032671 Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant…Gebauer Co. · 2004 · Recalled
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K021726Gebauer's Instant IceGebauer Co. · 2002 · cites it directly29descendants
- K030281Cryotron 2 Cryotherapy DeviceCryonic Medical North America · 2003 · 2 generations on14descendants
- K170810CryofosCryofos Medical GmbH · 2017 · 3 generations on13descendants
- K031036Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin…Gebauer Co. · 2003 · cites it directly11descendants
- K032671Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray)…Gebauer Co. · 2004 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991514 | Gebauer's Chloride Fine Nozze | Gebauer Co. | 1999 | — |
| +1 | K021726 | Gebauer's Instant Ice | Gebauer Co. | 2002 | 2 |
| +2 | K030281 | Cryotron 2 Cryotherapy Device | Cryonic Medical North America | 2003 | — |
| +3 | K170810 | Cryofos | Cryofos Medical GmbH | 2017 | — |
| +1 | K031036 | Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's… | Gebauer Co. | 2003 | 1 |
| +2 | K032671 | Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream… | Gebauer Co. | 2004 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | — | Ethyl Chloride, USP Fine Nozzle Named without a submission number | |
| * | — | Ethyl Chloride, USP Medium Nozzle Named without a submission number | |
| * | — | Ethyl Chloride, USP 100 g Tube Named without a submission number |
What descends from it? (30)
See all 303 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?
- Of its descendants, K021726 (Gebauer Co., 2002) has gone furthest, with 29 descendants of its own.
How does its category compare?
All MLY devicesMLY Vapocoolant Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Gebauer’s Ethyl Chloride (Fine and Medium Nozzles): Gebauer’s Ethyl Chloride is 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 and the temporary relief of minor sports injuries. It is also intended for the treatment of restricted motion associated with myofascial pain caused by trigger points.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991514: Gebauer's Chloride Fine Nozze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991514
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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