Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rebotix · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
188 daysmedian FDA review time
189 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250417 | Remanufactured EndoWrist Cobra Grasper (420190) | Rebotix | 2025-08-20 | 188 | 0 |
| K250539 | Remanufactured EndoWrist Tenaculum Forceps (420207) | Rebotix | 2025-08-19 | 176 | 0 |
| K250387 | Remanufactured EndoWrist Long Tip Forceps (420048) | Rebotix | 2025-08-19 | 189 | 0 |
| K250399 | Remanufactured EndoWrist Cadiere Forceps (420049) | Rebotix | 2025-08-19 | 188 | 0 |
| K241872 | Remanufactured EndoWrist ProGrasp Forceps (420093) | Rebotix | 2024-11-07 | 133 | 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