Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Xodus Medical, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
61 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260903 | Hot Pink Pad Warming System | Xodus Medical, Inc. | 2026-04-16 | 29 | 0 |
| K182080 | Scope Antifogging System | Xodus Medical, Inc. | 2018-09-19 | 48 | 0 |
| K081647 | ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE | Xodus Medical, Inc. | 2008-08-12 | 61 | 0 |
| K063587 | XODUS MEDICAL ANTI-FOG SOLUTION | Xodus Medical, Inc. | 2007-01-09 | 39 | 0 |
| K053433 | CAUTERY TIP CLEANER, MODEL 30500 | Xodus Medical, Inc. | 2006-01-19 | 41 | 3 |
| K053321 | LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER | Xodus Medical, Inc. | 2006-01-19 | 50 | 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