Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
NTB · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
476 daysmedian FDA review time
541 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150019 | TheraVision Ultrasound Ablation System and ACOUSTx Applicato | Acoustic Medsystems, Inc. | 2016-01-13 | 373 | 0 |
| K070779 | SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM | Misonix, Inc. | 2008-07-09 | 476 | 0 |
| K060346 | ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM | Ultrazonix Dnt AB | 2006-12-22 | 315 | 0 |
| K042096 | MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYST | Misonix, Inc. | 2006-01-26 | 540 | 0 |
| K040641 | ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODEL | Epicor Medical, Inc. | 2004-05-05 | 56 | 0 |
| K022894 | EPICOR MEDICAL ABLATION SYSTEM | Epicor Medical, Inc. | 2004-02-26 | 541 | 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