Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Xonics Medical Systems, Inc. — 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) |
|---|---|---|---|---|---|
| K827292 | MODEL IC 3000 | Xonics Medical Systems, Inc. | 1982-07-09 | 32 | 0 |
| K820593 | ESP SERIES (X-RAY GENERATORS | Xonics Medical Systems, Inc. | 1982-03-19 | 15 | 0 |
| K791298 | DIAGNOSTIC ULTRASOUND SYSTEM | Xonics Medical Systems, Inc. | 1979-09-27 | 73 | 0 |
| K770693 | X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC | Xonics Medical Systems, Inc. | 1977-08-03 | 112 | 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