510(k) Report

510(k) · Cleared

Cleared

Erbe Erbokryo CA Cryosurgical Unit & Accessories

K051509510(k) TraditionalCleared Jul 27, 200550-day reviewClass II21 CFR 878.4350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Erbe USA, Inc. · GEH Unit, Cryosurgical, Accessories

Cleared on Jul 27, 2005 as substantially equivalent to K934261 (Erbe Elektromedizin GmbH, 1994) after a 50-day review. Its family tree reaches back 1 generation to 1994. 1 of the 11 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.

Decided
Jul 27, 2005
Review
50 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K934261 (1994). 9 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.

Descendants, by year cleared 2015: 1 descendant cleared2020: 1 descendant cleared, 1 with a Class I recall12024: 2 descendants cleared2026: 4 descendants cleared2025: 1 descendant clearedK934261 · Erbokryo CA Cryosurgical System · Erbe Elektromedizin GmbH · 19941990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant, 1 with a Class I recall13 generations forward: 6 descendants4 generations forward: 1 descendant K934261 · Erbokryo CA Cryosurgical System · Erbe Elektromedizin GmbH · 19940
  1. Root · 1 generation backK934261 Erbokryo CA Cryosurgical SystemErbe Elektromedizin GmbH · 1994
  2. This deviceK051509 Erbe Erbokryo CA Cryosurgical Unit & AccessoriesErbe USA, Inc. · 2005
  3. Descendant · cites it directly · 8 of its ownK151041 ERBECRYO 2 Cryosurgical Unit with accessoriesErbe USA, Inc. · 2015
  4. Descendant · 2 generations on · 7 of its ownK190651 ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch…Erbe Elektromedizin GmbH · 2020 · Recalled (Class I)
  5. Descendant · 3 generations on · 1 of its ownK253230 ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2…Erbe Elektromedizin GmbH · 2026
  6. Descendant · 3 generations on · 1 of its ownK240932 HybridTherm SystemErbe Elektromedizin GmbH · 2024
  7. Descendant · 3 generations on · 0 of its ownK262420 Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo…Serpex Medical · 2026

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2015: 12020: 12024: 22025: 12026: 4
2015high 4 (2026) · low 0 (2016)2026

Class I recalls in this family

  • K190651 ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal…2 generations on · 2020

Most influential descendants

Showing 5 of 9 · See all
  • K151041ERBECRYO 2 Cryosurgical Unit with accessoriesErbe USA, Inc. · 2015 · cites it directly8descendants
  • K190651ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO…Erbe Elektromedizin GmbH · 2020 · 2 generations on7descendants
  • K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe…Erbe Elektromedizin GmbH · 2026 · 3 generations on1descendant
  • K240932HybridTherm SystemErbe Elektromedizin GmbH · 2024 · 3 generations on1descendant
  • K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K934261Erbokryo CA Cryosurgical SystemErbe Elektromedizin GmbH1994—
0 (this device)K051509Erbe Erbokryo CA Cryosurgical Unit & AccessoriesErbe USA, Inc.2005—
+1K151041ERBECRYO 2 Cryosurgical Unit with accessoriesErbe USA, Inc.2015—
+2K190651ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable…Erbe Elektromedizin GmbH2020Class I
+3K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit…Erbe Elektromedizin GmbH2026—
+3K240932HybridTherm SystemErbe Elektromedizin GmbH2024—
+3K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
202011
202420
202510
202640
FIG. 1 — Lineage of K051509, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K934261Erbokryo CA Cryosurgical System
Summary page 1
…50) Product Code: GEH, FAZ Legally Marketed ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories Predicate Device: - 510(k) Number: K934261 Device Description: is The ERBE…
Erbe Elektromedizin GmbH1994—

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151041ERBECRYO 2 Cryosurgical Unit with accessoriesErbe USA, Inc.20158

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 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K151041 (Erbe USA, Inc., 2015) has gone furthest, with 8 descendants of its own.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEH

10in 2025

2007: 62008: 12009: 42010: 42011: 72012: 42013: 42014: 62015: 112016: 152017: 122018: 62019: 62020: 82021: 62022: 62023: 82024: 92025: 102026 (partial year): 8
2007high 15 (2016) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEH

77in 2025

2007: 71 days median2009: 121 days median2010: 86 days median2011: 91 days median2012: 96 days median2013: 76 days median2014: 42 days median2015: 72 days median2016: 60 days median2017: 83 days median2018: 42 days median2019: 115 days median2020: 113 days median2021: 206 days median2022: 56 days median2023: 136 days median2024: 85 days median2025: 77 days median2026 (partial year): 148 days median
2007high 206 (2021) · low 42 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEH

2in 2023

2007: 32008: 22009: 132010: 42012: 32014: 22018: 12019: 12020: 372023: 22026 (partial year): 2
2007high 37 (2020) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEH

171in 2025

2007: 232008: 292009: 212010: 1732011: 612012: 912013: 912014: 572015: 972016: 1432017: 2162018: 2082019: 4552020: 2772021: 2132022: 2302023: 1642024: 1412025: 171
2007high 455 (2019) · low 21 (2009)2025

MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007671323
20081—229
200941211321
20104864173
2011791061
2012496391
2013476091
2014642257
20151172097
201615600143
201712830216
20186421208
201961151455
2020811337277
202162060213
20226560230
202381362164
20249850141
202510770171
202681482—

What is it indicated for?

The ERBE ERBOKRYO® CA 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 ERBE ERBOKRYO® CA 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 (I 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 (Cryorecanalization)

Indications for use as stated in the FDA summary.

More from Erbe USA, Inc.

39 FDA decisions under this applicant name. See the company

  • K221177Erbe's Tubing/Cap SetsErbe USA, Inc. · 20221 recall
  • K191438ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorErbe USA, Inc. · 2019
  • K190469ERBEFLO 2 Disposable Tubing SystemErbe USA, Inc. · 20191 recall
  • K182444ERBEFLO Olympus Scope Port ConnectorErbe USA, Inc. · 2018
  • K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. · 20161 recall

Recent decisions in GEH

The GEH category page

  • K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical · 2026
  • K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026
  • K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH · 2026
  • K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH · 2026
  • K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V. · 2026

https://510kreport.com/device/K051509 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051509: Erbe Erbokryo CA Cryosurgical Unit & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051509

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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