510(k) · Cleared
ClearedFrozen C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.M. Tech. Worldwide Co., Ltd. · GEH Unit, Cryosurgical, Accessories
Cleared on Oct 30, 2018 as substantially equivalent to K170810 (Cryofos Medical GmbH, 2017) after a 56-day review. Its family tree reaches back 4 generations to 1999. 6 later devices descend from it.
- Decided
- Oct 30, 2018
- Review
- 56 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K991514 (1999). 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK991514 Gebauer's Chloride Fine NozzeGebauer Co. · 1999
- 3 generations backK021726 Gebauer's Instant IceGebauer Co. · 2002 · Recalled
- 2 generations backK030281 Cryotron 2 Cryotherapy DeviceCryonic Medical North America · 2003
- 1 generation backK170810 CryofosCryofos Medical GmbH · 2017
- This deviceK182392 Frozen CB.M. Tech. Worldwide Co., Ltd. · 2018
- Descendant · cites it directly · 3 of its ownK201260 Dermal Cooling SystemR2 Technologies, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK203006 R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK213294 Dermal Cooling SystemR2 Technologies, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK193665 Frozen NYozma Bmtech Co., Ltd. · 2020
- Descendant · 4 generations on · 0 of its ownK253261 Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K201260Dermal Cooling SystemR2 Technologies, Inc. · 2020 · cites it directly3descendants
- K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021 · 2 generations on2descendants
- K213294Dermal Cooling SystemR2 Technologies, Inc. · 2022 · 3 generations on1descendant
- K193665Frozen NYozma Bmtech Co., Ltd. · 2020 · cites it directly1descendant
- K253261Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K991514 | Gebauer's Chloride Fine Nozze | Gebauer Co. | 1999 | — |
| −3 | K021726 | Gebauer's Instant Ice | Gebauer Co. | 2002 | 2 |
| −2 | K030281 | Cryotron 2 Cryotherapy Device | Cryonic Medical North America | 2003 | — |
| −1 | K170810 | Cryofos | Cryofos Medical GmbH | 2017 | — |
| 0 (this device) | K182392 | Frozen C | B.M. Tech. Worldwide Co., Ltd. | 2018 | — |
| +1 | K201260 | Dermal Cooling System | R2 Technologies, Inc. | 2020 | — |
| +2 | K203006 | R2 Dermabrasion Tip (for Dermal Cooling System) | R2 Technologies, Inc. | 2021 | — |
| +3 | K213294 | Dermal Cooling System | R2 Technologies, Inc. | 2022 | — |
| +1 | K193665 | Frozen N | Yozma Bmtech Co., Ltd. | 2020 | — |
| +4 | K253261 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 GEH? 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 GEH device
- #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 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 |
|---|---|---|---|
| * | K170810 | CryofosSummary page 4…Trade/proprietary Name CRYOFOS & Accessories Manufacturer CRYOFOS Medical Gmbh 510(k) Number K170810 Regulation & product code 21 CFR 878.4350 (GEH, MLY) Regulatory Class Class II… | 2017 |
What descends from it? (6)
2 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 19 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K201260 (R2 Technologies, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K170810.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · GEH
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEH
77in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEH
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GEH
171in 2025
MAUDE reports naming product code GEH, 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 | 6 | 71 | 3 | 23 |
| 2008 | 1 | — | 2 | 29 |
| 2009 | 4 | 121 | 13 | 21 |
| 2010 | 4 | 86 | 4 | 173 |
| 2011 | 7 | 91 | 0 | 61 |
| 2012 | 4 | 96 | 3 | 91 |
| 2013 | 4 | 76 | 0 | 91 |
| 2014 | 6 | 42 | 2 | 57 |
| 2015 | 11 | 72 | 0 | 97 |
| 2016 | 15 | 60 | 0 | 143 |
| 2017 | 12 | 83 | 0 | 216 |
| 2018 | 6 | 42 | 1 | 208 |
| 2019 | 6 | 115 | 1 | 455 |
| 2020 | 8 | 113 | 37 | 277 |
| 2021 | 6 | 206 | 0 | 213 |
| 2022 | 6 | 56 | 0 | 230 |
| 2023 | 8 | 136 | 2 | 164 |
| 2024 | 9 | 85 | 0 | 141 |
| 2025 | 10 | 77 | 0 | 171 |
| 2026 | 8 | 148 | 2 | — |
What is it indicated for?
The FROZEN C, hyperbaric CO2 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/K182392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182392: Frozen C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182392
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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