510(k) · Cleared
ClearedCryotron 2 Cryotherapy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryonic Medical North America · MLY Vapocoolant Device
Cleared on Aug 20, 2003 as substantially equivalent to K021726 (Gebauer Co., 2002) after a 205-day review. Its family tree reaches back 2 generations to 1999. 14 later devices descend from it.
- Decided
- Aug 20, 2003
- Review
- 205 days
- Class
- Class U
- Product code
- MLY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991514 (1999). 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK991514 Gebauer's Chloride Fine NozzeGebauer Co. · 1999
- 1 generation backK021726 Gebauer's Instant IceGebauer Co. · 2002 · Recalled
- This deviceK030281 Cryotron 2 Cryotherapy DeviceCryonic Medical North America · 2003
- Descendant · cites it directly · 13 of its ownK170810 CryofosCryofos Medical GmbH · 2017
- Descendant · 2 generations on · 6 of its ownK182392 Frozen CB.M. Tech. Worldwide Co., Ltd. · 2018
- Descendant · 2 generations on · 5 of its ownK203481 CryoVIVERecensmedical, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK220674 TargetCoolRecensmedical, Inc. · 2022
- Descendant · 4 generations on · 3 of its ownK221234 TargetCoolRecensmedical, Inc. · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K170810CryofosCryofos Medical GmbH · 2017 · cites it directly13descendants
- K182392Frozen CB.M. Tech. Worldwide Co., Ltd. · 2018 · 2 generations on6descendants
- K203481CryoVIVERecensmedical, Inc. · 2021 · 2 generations on5descendants
- K220674TargetCoolRecensmedical, Inc. · 2022 · 3 generations on4descendants
- K221234TargetCoolRecensmedical, Inc. · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991514 | Gebauer's Chloride Fine Nozze | Gebauer Co. | 1999 | — |
| −1 | K021726 | Gebauer's Instant Ice | Gebauer Co. | 2002 | 2 |
| 0 (this device) | K030281 | Cryotron 2 Cryotherapy Device | Cryonic Medical North America | 2003 | — |
| +1 | K170810 | Cryofos | Cryofos Medical GmbH | 2017 | — |
| +2 | K182392 | Frozen C | B.M. Tech. Worldwide Co., Ltd. | 2018 | — |
| +2 | K203481 | CryoVIVE | Recensmedical, Inc. | 2021 | — |
| +3 | K220674 | TargetCool | Recensmedical, Inc. | 2022 | — |
| +4 | K221234 | TargetCool | Recensmedical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K021726 | Gebauer's Instant IceSummary page 1…2" Cryotherapy Device COMMON OR USUAL NAME: Cryotherapy Device DEVICE CLASSIFICATfON: Class I1 PREDICATE DEVICES: Gebauer's Instant Ice, K021726, Product Code MLY DEVICE DESCRIPTION: The CRYOTRON 2mCryotherapy Device delivers a topical spray… | 2002 |
What descends from it? (14)
See all 142 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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K170810 (Cryofos Medical GmbH, 2017) has gone furthest, with 13 descendants of its own.
- 3 other devices also cite its predicate K021726.
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?
The CRYOTRON 2" Cryotherapy Device is for use when cold therapy is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030281 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030281: Cryotron 2 Cryotherapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030281
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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