510(k) · Cleared
ClearedSyringe Holder accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vapocoolshot, Inc. · MLY Vapocoolant Device
Cleared on Aug 12, 2020 as substantially equivalent to K193349 (Vapocoolshot, Inc., 2020) and 1 other predicate after a 93-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Aug 12, 2020
- Review
- 93 days
- Class
- Class U
- Product code
- MLY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K991514 (1999). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK991514 Gebauer's Chloride Fine NozzeGebauer Co. · 1999
- 5 generations backK021726 Gebauer's Instant IceGebauer Co. · 2002 · Recalled
- 4 generations backK031036 Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07…Gebauer Co. · 2003 · Recalled
- 3 generations backK032671 Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant…Gebauer Co. · 2004 · Recalled
- 2 generations backK172028 Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray…Gebauer Company · 2017
- 1 generation backK193349 Vapocoolshot MistVapocoolshot, Inc. · 2020
- This deviceK201248 Syringe Holder accessoryVapocoolshot, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K991514 | Gebauer's Chloride Fine Nozze | Gebauer Co. | 1999 | — |
| −5 | K021726 | Gebauer's Instant Ice | Gebauer Co. | 2002 | 2 |
| −4 | K031036 | Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's… | Gebauer Co. | 2003 | 1 |
| −3 | K032671 | Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream… | Gebauer Co. | 2004 | 3 |
| −2 | K172028 | Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium… | Gebauer Company | 2017 | — |
| −1 | K193349 | Vapocoolshot Mist | Vapocoolshot, Inc. | 2020 | — |
| 0 (this device) | K201248 | Syringe Holder accessory | Vapocoolshot, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K193349 | Vapocoolshot MistSummary page 4…Contact person: Neil Ross Chief scientist [email protected] Date Prepared: June 12, 2020 2. Subject device: Name/Classification Syringe Holder accessory for K193349 Special Controls: None Device Class: unclassified Review panel: Physical Medicine Product code: MLY 3. Trade Name of Subject Devi… | 2020 |
| * | K093951 | Ouchless Model PN10114Summary page 4…uroethane) Device: Refrigerant, Topical (Vapocoolant) Device Class: Unclassified Review panel: Physical Medicine Product code: MLY Predicate 1: Ouchless Occam Design LLC K093951 Basis for Submission: New accessory Device Page 1 of 5 L IL IIL Syringe Holder accessory- Traditional 510(k)… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 7 ancestors have a recall of any class.
How does its category compare?
All MLY devicesMLY Vapocoolant Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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?
The Vapocoolshot Mist is intended for topical application to skin, intact mucous membrane (oral cavity, nasal passageways, lips) and minor open wounds. The Vapocoolshot Mist is used to target and minimize cooling area for lessening pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical procedures (such as lancing boils, incision, drainage of small abscesses and sutures) and the temporary relief of minor sports…
Read the full statement (114 words)
The Vapocoolshot Mist is intended for topical application to skin, intact mucous membrane (oral cavity, nasal passageways, lips) and minor open wounds. The Vapocoolshot Mist is used to target and minimize cooling area for lessening pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical procedures (such as lancing boils, incision, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts, and abrasions)
The Syringe Holder accessory is intended to be attached to the Nozzle of the Vapocoolshot Mist and allows for the attachment of a user supplied syringe 1cc (4.5mm) to 3 cc (10.8mm) in diameter to facilitate the injection procedure following Vapocoolshot Mist application.
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/K201248 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201248: Syringe Holder accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201248
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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