510(k) · Cleared
ClearedERBECRYO 2 Cryosurgical Unit with accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erbe USA, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on May 4, 2015 as substantially equivalent to K051509 (Erbe USA, Inc., 2005) after a 14-day review. Its family tree reaches back 2 generations to 1994. 1 of the 11 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- May 4, 2015
- Review
- 14 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934261 (1994). 8 later devices descend from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK934261 Erbokryo CA Cryosurgical SystemErbe Elektromedizin GmbH · 1994
- 1 generation backK051509 Erbe Erbokryo CA Cryosurgical Unit & AccessoriesErbe USA, Inc. · 2005
- This deviceK151041 ERBECRYO 2 Cryosurgical Unit with accessoriesErbe USA, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK190651 ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch…Erbe Elektromedizin GmbH · 2020 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK253230 ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2…Erbe Elektromedizin GmbH · 2026
- Descendant · 2 generations on · 1 of its ownK240932 HybridTherm SystemErbe Elektromedizin GmbH · 2024
- Descendant · 2 generations on · 0 of its ownK262420 Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo…Serpex Medical · 2026
- Descendant · 2 generations on · 0 of its ownK261068 Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190651 ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal…cites it directly · 2020
Most influential descendants
Showing 5 of 8 · See all- K190651ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO…Erbe Elektromedizin GmbH · 2020 · cites it directly7descendants
- K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe…Erbe Elektromedizin GmbH · 2026 · 2 generations on1descendant
- K240932HybridTherm SystemErbe Elektromedizin GmbH · 2024 · 2 generations on1descendant
- K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical · 2026 · 2 generations on0descendants
- K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934261 | Erbokryo CA Cryosurgical System | Erbe Elektromedizin GmbH | 1994 | — |
| −1 | K051509 | Erbe Erbokryo CA Cryosurgical Unit & Accessories | Erbe USA, Inc. | 2005 | — |
| 0 (this device) | 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 |
| +2 | K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit… | Erbe Elektromedizin GmbH | 2026 | — |
| +2 | K240932 | HybridTherm System | Erbe Elektromedizin GmbH | 2024 | — |
| +2 | K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | Serpex Medical | 2026 | — |
| +2 | K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | Serpex Medical | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 1 |
| 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 |
|---|---|---|---|
| * | K051509 | Erbe Erbokryo CA Cryosurgical Unit & AccessoriesSummary page 4…Submission: Traditional 510(k) Date of Summary: March 2015 Predicate device: ERBE ERBOKRYO® CA and Accessories; K051509 Device Description The ERBECRYO 2 Cryosurgical Unit and Accessories consists of a cryosurgical unit, probes… | 2005 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190651 | ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO… Class I | 2020 | 7 |
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 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 11.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K190651 (Erbe Elektromedizin GmbH, 2020) has gone furthest, with 7 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. 2015, 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 devitalization (destruction) of tissue during surgical procedures by the application of extreme cold and for removal of foreign bodies, mucous plugs, necrotic tissue, and tissue biopsy by cryoadhesion. Clinical Indications for Cryosurgery: Gynecology: Cervical Erosions, Cervical Polyps, Condylomas, Chronic Cervicitis, Vulva Carcinoma (palliative), Neoplasia Dermatology: Leukoplakia…
Read the full statement (131 words)
The ERBECRYO 2 Cryosurgical Unit and Accessories are intended for devitalization (destruction) of tissue during surgical procedures by the application of extreme cold and for removal of foreign bodies, mucous plugs, necrotic tissue, and tissue biopsy by cryoadhesion.
Clinical Indications for Cryosurgery:
Gynecology: Cervical Erosions, Cervical Polyps, Condylomas, Chronic Cervicitis, Vulva Carcinoma (palliative), Neoplasia
Dermatology: Leukoplakia, Fibroma, Condylomas, Basal Cell Carcinoma, Skin Tumor (palliative), Warts, Naephus
Ophthalmology: Ablatio Retinae, Glaucoma, Lid Tumor
ENT: Leukoplakia, Inoperable Tumor (palliative), Laryngeal Papilloma, Fibroma, Angioma, Haemangioma
Thoracic Surgery: Post-Operative
Urology: Prostate Tumor (palliative), Condylomas, Penile Tumor (palliative)
Phlebology: Varicose Veins of the Lower Limbs (Cryo Stripping)
Proctology: Hemorrhoids (1st and 2nd Degree), Pari-Anal Condylomas, Anal Tumor (palliative), Rectal Tumor (palliative), Acute Anal Fissures
Pulmonology: Tumors, Granulomatous Tissue, Malignant Lesions (palliative)
Pneumology: Tracheobronchial Stenoses (Cryo re-canalization)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151041: ERBECRYO 2 Cryosurgical Unit with accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151041
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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