Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IceCure Medical , Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260377 | XSense Cryoablation System with CryoProbes | IceCure Medical , Ltd. | 2026-02-24 | 19 | 0 |
| K240892 | XSense Cryoablation System with Cryoprobes | IceCure Medical , Ltd. | 2024-06-28 | 88 | 0 |
| K183213 | IceSense 3, ProSense, MultiSense | IceCure Medical , Ltd. | 2019-12-20 | 396 | 0 |
| K102360 | ICESENCE 3 | IceCure Medical , Ltd. | 2010-11-29 | 102 | 1 |
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