510(k) · Cleared
ClearedCryoVIVE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Recensmedical, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on May 13, 2021 as substantially equivalent to K190407 (Cryoconcepts LP, 2019) and 2 other predicates after a 167-day review. Its family tree reaches back 4 generations to 1999. 5 later devices descend from it.
- Decided
- May 13, 2021
- Review
- 167 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K991514 (1999). 8 ancestors in all. 5 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 deviceK203481 CryoVIVERecensmedical, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK220674 TargetCoolRecensmedical, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK221234 TargetCoolRecensmedical, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK230599 TargetCool™Recensmedical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK253114 TargetCool™ (RM-DT02W)Recensmedical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK253348 TargetCool-eRecensmedical, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K220674TargetCoolRecensmedical, Inc. · 2022 · cites it directly4descendants
- K221234TargetCoolRecensmedical, Inc. · 2022 · 2 generations on3descendants
- K230599TargetCool™Recensmedical, Inc. · 2023 · cites it directly2descendants
- K253114TargetCool™ (RM-DT02W)Recensmedical, Inc. · 2025 · 2 generations on0descendants
- K253348TargetCool-eRecensmedical, Inc. · 2025 · 2 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) | K203481 | CryoVIVE | Recensmedical, Inc. | 2021 | — |
| +1 | K220674 | TargetCool | Recensmedical, Inc. | 2022 | — |
| +2 | K221234 | TargetCool | Recensmedical, Inc. | 2022 | — |
| +1 | K230599 | TargetCool™ | Recensmedical, Inc. | 2023 | — |
| +2 | K253114 | TargetCool™ (RM-DT02W) | Recensmedical, Inc. | 2025 | — |
| +2 | K253348 | TargetCool-e | Recensmedical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K190407 | CryoLabSummary page 4…ion Panel: General & Plastic Surgery Product code: GEH, MLY 3. PRIMARY PREDICATE DEVICE 510(k) Number: K190407 Trade name: CryoLab Classification name: Cryosurgical Unit and Accessories 510(k)… | 2019 |
| * | K170810 | CryofosSummary page 5…General & Plastic Surgery Product code: GEH 4. SECOND PREDICATE DEVICE 510(k) Number: K170810 Trade name: Cryofos Classification name: Cryosurgical Unit and… | 2017 |
| * | K172769 | CryOmega FlexxSummary page 5…General & Plastic Surgery Product code: GEH, MLY 5. REFERENCE DEVICE INFORMATION 510(k) Number: K172769 Trade name: CryOmega Flexx Classification name: Cryosurgical U… | 2017 |
What descends from it? (5)
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 22 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K220674 (Recensmedical, Inc., 2022) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 CryoVIVE(Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures
- Molluscum Contagiosum
- Skin Tags
- Actinic Keratosis
- Lentigo
- Verruca Plana
- Verruca Vulgaris
- Verruca Lesions
- Genital Lesions
- Seborrheic Keratosis
The CryoVIVE(Cooling mode) 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203481: CryoVIVE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203481
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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