Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GXH — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
60 daysmedian FDA review time
184 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | AtriCure, Inc. | 2025-04-10 | 59 | 0 |
| K243677 | iovera° System | Pacira Biosciences, Inc. | 2024-12-26 | 29 | 0 |
| K243157 | AtriCure cryoICE BOX (ACM) | AtriCure, Inc. | 2024-10-29 | 29 | 0 |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cry | AtriCure, Inc. | 2023-10-26 | 29 | 0 |
| K220656 | iovera System | Pacira Biosciences, Inc. | 2022-05-20 | 74 | 0 |
| K211334 | Iovera System | Pacira Pharmaceuticals, Inc. | 2021-09-10 | 130 | 0 |
| K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryo | AtriCure, Inc. | 2020-12-23 | 281 | 0 |
| K182565 | AtriCure cryoICE cryoSPHERE cryoablation probe | AtriCure, Inc. | 2018-11-09 | 52 | 0 |
| K173763 | iovera system | Myoscience, Inc. | 2018-02-28 | 79 | 0 |
| K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2) | AtriCure, Inc. | 2018-02-15 | 29 | 0 |
| K161835 | iovera system | Myoscience, Inc. | 2017-03-24 | 262 | 0 |
| K142866 | Myoscience iovera system | Myoscience, Inc. | 2015-01-21 | 112 | 1 |
| K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | 2014-11-25 | 106 | 0 |
| K133453 | IOVERA | Myoscience, Inc. | 2014-03-24 | 132 | 0 |
| K123516 | CRYO-TOUCH IV | Myoscience, Inc. | 2013-01-10 | 57 | 1 |
| K120415 | CRYO-TOUCH III | Myoscience, Inc. | 2012-06-22 | 133 | 0 |
| K102021 | CRYO-TOUCH II | Myoscience, Inc. | 2010-09-17 | 60 | 0 |
| K100447 | MYOSCIENCE CRYO-TOUCH | Myoscience, Inc. | 2010-06-25 | 128 | 0 |
| K050272 | CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS | Cryomedical Instruments, Ltd. | 2005-03-24 | 48 | 0 |
| K031482 | CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTA | Cryomedical Instruemts , Ltd. | 2003-07-10 | 59 | 0 |
| K854334 | PAINBLOCKER WA5000 | Wallach Surgical Devices, Inc. | 1986-04-30 | 184 | 0 |
| K831963 | CRYOMEDICS NEUROSTAT | Spembly Medical , Ltd. | 1983-08-12 | 56 | 0 |
| K781302 | NEUROSTAT, LLOYD | Spembly Medical , Ltd. | 1978-08-15 | 18 | 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