510(k) · Cleared
Recalled · Class I · 2026ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erbe Elektromedizin GmbH · GEH Unit, Cryosurgical, Accessories
Cleared on Jan 7, 2020 as substantially equivalent to K151041 (Erbe USA, Inc., 2015) after a 300-day review. Its family tree reaches back 3 generations to 1994. 1 of the 11 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it. It has been recalled 4 times, including 3 Class I recalls.
- Decided
- Jan 7, 2020
- Review
- 300 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 4 (3 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to K934261 (1994). 7 later devices descend from it, 6 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK934261 Erbokryo CA Cryosurgical SystemErbe Elektromedizin GmbH · 1994
- 2 generations backK051509 Erbe Erbokryo CA Cryosurgical Unit & AccessoriesErbe USA, Inc. · 2005
- 1 generation backK151041 ERBECRYO 2 Cryosurgical Unit with accessoriesErbe USA, Inc. · 2015
- This deviceK190651 ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch…Erbe Elektromedizin GmbH · 2020
- Descendant · cites it directly · 1 of its ownK253230 ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2…Erbe Elektromedizin GmbH · 2026
- Descendant · cites it directly · 1 of its ownK240932 HybridTherm SystemErbe Elektromedizin GmbH · 2024
- Descendant · cites it directly · 0 of its ownK262420 Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo…Serpex Medical · 2026
- Descendant · cites it directly · 0 of its ownK261068 Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026
- Descendant · cites it directly · 0 of its ownK261806 ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe…Erbe Elektromedizin GmbH · 2026 · cites it directly1descendant
- K240932HybridTherm SystemErbe Elektromedizin GmbH · 2024 · cites it directly1descendant
- K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical · 2026 · cites it directly0descendants
- K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026 · cites it directly0descendants
- K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934261 | Erbokryo CA Cryosurgical System | Erbe Elektromedizin GmbH | 1994 | — |
| −2 | K051509 | Erbe Erbokryo CA Cryosurgical Unit & Accessories | Erbe USA, Inc. | 2005 | — |
| −1 | K151041 | ERBECRYO 2 Cryosurgical Unit with accessories | Erbe USA, Inc. | 2015 | — |
| 0 (this device) | K190651 | ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable… | Erbe Elektromedizin GmbH | 2020 | — |
| +1 | K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit… | Erbe Elektromedizin GmbH | 2026 | — |
| +1 | K240932 | HybridTherm System | Erbe Elektromedizin GmbH | 2024 | — |
| +1 | K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | Serpex Medical | 2026 | — |
| +1 | K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | Serpex Medical | 2026 | — |
| +1 | K261806 | ERBECRYO 2 Cryosurgical Unit and Accessories | Erbe Elektromedizin GmbH | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K151041 | ERBECRYO 2 Cryosurgical Unit with accessoriesSummary page 4…GEH Legally Marketed Predicate Device: ERBE ERBECRYO 2 Cryosurgical Unit and Accessories - K151041 Device Description: The ERBECRYO® 2 Unit and Accessories are manufactured with various metals, plastics, silicone, adhesive, etc… | 2015 |
What descends from it? (7)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe… | 2026 | 1 |
| K240932 | HybridTherm System | 2024 | 1 |
| K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | 2026 | 0 |
| K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | 2026 | 0 |
| K261806 | ERBECRYO 2 Cryosurgical Unit and Accessories | 2026 | 0 |
| K240776 | Celsio Flexible Cryocatheter System | 2024 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2026 | Class II | Z-2938-2026 | Device Design | A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the… |
| Feb 12, 2026 | Class I | Z-1568-2026 | Process control | Probes may rupture/burst during activation |
| Feb 12, 2026 | Class I | Z-1567-2026 | Process control | Probes may rupture/burst during activation |
| Feb 12, 2026 | Class I | Z-1566-2026 | Process control | Probes may rupture/burst during activation |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K253230 (Erbe Elektromedizin GmbH, 2026) has gone furthest, with 1 descendant 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. 2020, 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 ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion and devitalization (destruction) of tissue by the application of extreme cold.
The Erbe Flexible Cryoprobes are intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190651 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190651: ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190651
Report an extraction error
Are you the manufacturer?
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