Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GEH — Predicate Candidate Screening
263 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
238 days90th percentile
263clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge ( | Serpex Medical | 2026-06-30 | 90 | 0 |
| K261806 | ERBECRYO 2 Cryosurgical Unit and Accessories | Erbe Elektromedizin GmbH | 2026-06-09 | 8 | 0 |
| K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cry | Erbe Elektromedizin GmbH | 2026-04-22 | 205 | 0 |
| K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | Medical Brands Laboratories B.V. | 2026-04-02 | 262 | 0 |
| K260377 | XSense Cryoablation System with CryoProbes | IceCure Medical , Ltd. | 2026-02-24 | 19 | 0 |
| K251928 | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01) | Medinice S.A. | 2026-02-13 | 235 | 0 |
| K251524 | Dr. Yglo Skin Tag Remover | Theotclab Healthcare B.V. | 2026-01-12 | 241 | 0 |
| K250742 | Focused Cryotherapy System | Focused Cryo, Inc. | 2025-12-09 | 273 | 0 |
| K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025-10-16 | 28 | 0 |
| K253114 | TargetCool™ (RM-DT02W) | Recensmedical, Inc. | 2025-10-16 | 22 | 0 |
| K253348 | TargetCool-e | Recensmedical, Inc. | 2025-10-15 | 15 | 0 |
| K252903 | Verruca-Freeze H Plus | Cryosurgery, Inc. | 2025-10-10 | 29 | 0 |
| K251493 | Skin Clinic Freeze Point for Warts and Skin Tags | Cryoconcepts LP | 2025-05-22 | 7 | 0 |
| K242932 | Skin Clinic Nitro Clear Wart Remover | Cryoconcepts LP | 2025-04-15 | 202 | 0 |
| K243487 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025-03-13 | 125 | 0 |
| K243042 | Co-Ablation System with Sterile Co-Ablation Probe | Hygea Medical Technology Co., Ltd. | 2025-01-29 | 124 | 0 |
| K242288 | Advanced Cryo Wart Remover | Medical Brands Laboratories B.V. | 2025-01-21 | 172 | 0 |
| K243454 | Verruca-Freeze H | Cryosurgery, Inc. | 2024-12-03 | 26 | 0 |
| K242803 | Compound W Skin Tag Remover | Medtech Products, Inc. | 2024-11-06 | 50 | 0 |
| K242625 | Freeze Point & Private Label Versions | Cryoconcepts LP | 2024-10-25 | 52 | 0 |
| K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1. | Boston Scientific Corp | 2024-10-18 | 7 | 0 |
| K240776 | Celsio Flexible Cryocatheter System | Endocision Technologies, Inc. | 2024-09-24 | 187 | 0 |
| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation Syst | Pentax of America, Inc. | 2024-07-24 | 159 | 0 |
| K240892 | XSense Cryoablation System with Cryoprobes | IceCure Medical , Ltd. | 2024-06-28 | 88 | 0 |
| K240106 | Histofreezer V | Cryoconcepts LP | 2024-06-10 | 146 | 0 |
| K234002 | ICEfx Cryoablation System (FPRCH8000-02) | Boston Scientific | 2024-03-13 | 85 | 2 |
| K233347 | Verruca-Freeze® H | Cryosurgery, Inc. | 2023-12-04 | 66 | 0 |
| K231661 | CryoThin™ Surgical System and Accessories | Medinux (Tianjin) Technologies Co., Ltd. | 2023-11-27 | 173 | 0 |
| K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S | Boston Scientific | 2023-11-22 | 84 | 1 |
| K230551 | Visual-ICE Cryoablation System | Boston Scientific Corporation | 2023-08-08 | 161 | 0 |
| K230599 | TargetCool™ | Recensmedical, Inc. | 2023-06-22 | 111 | 0 |
| K221897 | Hydrozid Precise | Bibawo Medical A/S | 2023-05-30 | 334 | 0 |
| K222356 | Claritag Advanced | Dgi Technologies | 2023-05-18 | 287 | 0 |
| K230271 | ISOLIS Cryoprobe | Varian Medical Systems, Inc. | 2023-03-28 | 56 | 0 |
| K223369 | truFreeze Console, PN CC301; Aire PV Passive Venting Cathete | STERIS Corporation | 2022-12-02 | 28 | 0 |
| K222272 | truFreeze Console, PN CC301; Aire PV Passive Venting Cathete | STERIS Corporation | 2022-08-18 | 20 | 0 |
| K221234 | TargetCool | Recensmedical, Inc. | 2022-07-22 | 84 | 0 |
| K211099 | Freeze’n Clear Skin Clinic Warts & Tags | Cryoconcepts LP | 2022-06-17 | 430 | 0 |
| K220674 | TargetCool | Recensmedical, Inc. | 2022-03-31 | 23 | 0 |
| K211149 | Urethral Warming Catheter Kit | Varian Medical Systems, Inc. | 2022-01-05 | 261 | 0 |
| K212814 | C2 CryoBalloon Ablation System | Pentax of America, Inc. | 2021-11-29 | 87 | 0 |
| K210310 | CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236m | Nuance Medical, LLC | 2021-10-22 | 261 | 0 |
| K201740 | Hydrozid | Medilink A/S | 2021-07-07 | 377 | 0 |
| K203481 | CryoVIVE | Recensmedical, Inc. | 2021-05-13 | 167 | 0 |
| K210529 | Dr. Yglo Wart Remover | Theotclab Healthcare B.V. | 2021-05-06 | 72 | 0 |
| K201366 | Forwarts | Pronova Laboratories BV | 2021-01-21 | 244 | 0 |
| K201183 | Vortex Radial Spray Catheter | CSA Medical, Inc. | 2020-12-07 | 220 | 0 |
| K203024 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Sta | Pentax of America, Inc. | 2020-11-24 | 53 | 0 |
| K203032 | IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, Ic | Galil Medical, Inc. | 2020-11-02 | 28 | 0 |
| K201260 | Dermal Cooling System | R2 Technologies, Inc. | 2020-09-24 | 136 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda