510(k) · Cleared
ClearedERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
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 Apr 22, 2026 as substantially equivalent to K190651 (Erbe Elektromedizin GmbH, 2020) after a 205-day review. Its family tree reaches back 4 generations to 1994. 1 of the 6 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Apr 22, 2026
- Review
- 205 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K934261 (1994). 1 later device descends from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK934261 Erbokryo CA Cryosurgical SystemErbe Elektromedizin GmbH · 1994
- 3 generations backK051509 Erbe Erbokryo CA Cryosurgical Unit & AccessoriesErbe USA, Inc. · 2005
- 2 generations backK151041 ERBECRYO 2 Cryosurgical Unit with accessoriesErbe USA, Inc. · 2015
- 1 generation backK190651 ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch…Erbe Elektromedizin GmbH · 2020 · Recalled (Class I)
- This deviceK253230 ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2…Erbe Elektromedizin GmbH · 2026
- Descendant · cites it directly · 0 of its ownK261806 ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH · 2026
Class I recalls in this family
- K190651 ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal…direct predicate · 2020
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −4 | K934261 | Erbokryo CA Cryosurgical System | Erbe Elektromedizin GmbH | 1994 | — |
| −3 | K051509 | Erbe Erbokryo CA Cryosurgical Unit & Accessories | Erbe USA, Inc. | 2005 | — |
| −2 | K151041 | ERBECRYO 2 Cryosurgical Unit with accessories | Erbe USA, Inc. | 2015 | — |
| −1 | K190651 | ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable… | Erbe Elektromedizin GmbH | 2020 | Class I |
| 0 (this device) | K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit… | Erbe Elektromedizin GmbH | 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 |
|---|---|---|
| 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.
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 |
|---|---|---|---|
| * | K190651 | ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO…Summary page 5…Code: GEH Legally Marketed Predicate Devices ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651 Page 1 of 5 Erbe Elektromediz… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261806 | ERBECRYO 2 Cryosurgical Unit and Accessories | 2026 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K190651ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch…Erbe Elektromedizin GmbH · 2020 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 32 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K261806 (Erbe Elektromedizin GmbH, 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K190651.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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/K253230 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253230: ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253230
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026