Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Galil Medical, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
178 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203032 | IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, Ic | Galil Medical, Inc. | 2020-11-02 | 28 | 0 |
| K200061 | HEATfx Microwave Ablation System, HEATfx Microwave Ablation | Galil Medical, Inc. | 2020-07-09 | 178 | 0 |
| K181153 | ICEfx Cryoablation System | Galil Medical, Inc. | 2018-05-15 | 14 | 0 |
| K173037 | Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction | Galil Medical, Inc. | 2017-11-21 | 54 | 0 |
| K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1 | Galil Medical, Inc. | 2015-03-05 | 79 | 0 |
| K123865 | VISUAL-ICE CRYOABLATION SYSTEM | Galil Medical, Inc. | 2013-02-06 | 51 | 0 |
| K113860 | VISUAL-ICE CRYOABLATION SYSTEM | Galil Medical, Inc. | 2012-03-12 | 73 | 1 |
| K111859 | ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEE | Galil Medical, Inc. | 2011-10-07 | 99 | 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