510(k) · Cleared
ClearedCRYO Arctic, CRYO Penguin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryoscience North America, Inc. · MLY Vapocoolant Device
Cleared on May 25, 2022 as substantially equivalent to K030281 (Cryonic Medical North America, 2003) and 1 other predicate after a 526-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- May 25, 2022
- Review
- 526 days
- Class
- Class U
- Product code
- MLY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K991514 (1999). 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 backK030281 Cryotron 2 Cryotherapy DeviceCryonic Medical North America · 2003
- 3 generations backK170810 CryofosCryofos Medical GmbH · 2017
- 2 generations backK182392 Frozen CB.M. Tech. Worldwide Co., Ltd. · 2018
- 1 generation backK193665 Frozen NYozma Bmtech Co., Ltd. · 2020
- This deviceK203661 CRYO Arctic, CRYO PenguinCryoscience North America, Inc. · 2022
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 | K030281 | Cryotron 2 Cryotherapy Device | Cryonic Medical North America | 2003 | — |
| −3 | K170810 | Cryofos | Cryofos Medical GmbH | 2017 | — |
| −2 | K182392 | Frozen C | B.M. Tech. Worldwide Co., Ltd. | 2018 | — |
| −1 | K193665 | Frozen N | Yozma Bmtech Co., Ltd. | 2020 | — |
| 0 (this device) | K203661 | CRYO Arctic, CRYO Penguin | Cryoscience North America, Inc. | 2022 | — |
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 |
|---|---|---|---|
| * | K030281 | Cryotron 2 Cryotherapy DeviceSummary page 5…1 5. Legally Marketed Predicate Device(s) Primary predicate device: Device Name: CRYOTRON 2® Cryotherapy Device 510(k) number: K030281 Manufacturer: CRYONIC MEDICAL NORTH AMERICA Secondary predicate device: Device name: FROZEN N 510(k) number:… | 2003 |
| * | K193665 | Frozen NSummary page 5…herapy Device 510(k) number: K030281 Manufacturer: CRYONIC MEDICAL NORTH AMERICA Secondary predicate device: Device name: FROZEN N 510(k) number: K193665 Manufacturer: B.M. Tech Worldwide Co., Ltd (formerly Yozma BMTech Co. Ltd.) 6. Indication for Use Statement The CRYO Pe… | 2020 |
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 23 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K030281.
How does its category compare?
All MLY devicesMLY Vapocoolant Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 CRYO Penguin is indicated 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/K203661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203661: CRYO Arctic, CRYO Penguin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203661
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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