510(k) · Cleared
ClearedFreezeSpray TA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryosurgery, Inc. · MLY Vapocoolant Device
Cleared on Sep 5, 2026 as substantially equivalent to K162218 (Nuance Medical, LLC, 2016) and 1 other predicate after a 107-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Sep 5, 2026
- Review
- 107 days
- Class
- Class U
- Product code
- MLY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K991514 (1999). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK991514 Gebauer's Chloride Fine NozzeGebauer Co. · 1999
- 4 generations backK021726 Gebauer's Instant IceGebauer Co. · 2002 · Recalled
- 3 generations backK031036 Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07…Gebauer Co. · 2003 · Recalled
- 2 generations backK032671 Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant…Gebauer Co. · 2004 · Recalled
- 1 generation backK162218 Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist…Nuance Medical, LLC · 2016
- This deviceK261684 FreezeSpray TACryosurgery, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K991514 | Gebauer's Chloride Fine Nozze | Gebauer Co. | 1999 | — |
| −4 | K021726 | Gebauer's Instant Ice | Gebauer Co. | 2002 | 2 |
| −3 | 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 |
| −1 | K162218 | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray… | Nuance Medical, LLC | 2016 | — |
| 0 (this device) | K261684 | FreezeSpray TA | Cryosurgery, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K162218 | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102Summary page 5…MLY Class Unclassified 5. Primary Predicate Device Device Name Pain Freeze™ 510(k) Number K162218 Regulation Unclassified Product Code MLY Class Unclassified 6. S… | 2016 |
| * | K172028 | Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Summary page 5…MLY Class Unclassified 6. Secondary Predicate Device Device Name Gebauer's Pain Ease 510(k) Number K172028 Regulation Unclassified Page 1… | 2017 |
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 27 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K162218.
How does its category compare?
All MLY devicesMLY Vapocoolant Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
FreezeSpray TA Mist Spray and Medium Stream Spray are vapocoolant (skin refrigerant) intended for topical application
to skin, intact mucous membranes (oral cavity, nasal passageways, and the lips), and minor open wounds.
The device is intended to control pain associated with minor surgical procedures (such as lancing boils, incisions, drainage
of small abscesses, and sutures), injections (including venipuncture, IV starts, and cosmetic procedures), and the
temporary relief of minor sports injuries (such as sprains, bruising, cuts, and abrasions).
The Medium Stream Spray is also intended for the management of myofascial pain, restricted motion, and muscle tension.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261684: FreezeSpray TA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261684
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026