Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rebound Therapeutics — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
345 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203745 | AURORA Evacuator +Coag | Rebound Therapeutics | 2021-12-02 | 345 | 0 |
| K201840 | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope Sys | Rebound Therapeutics | 2020-11-04 | 125 | 1 |
| K201637 | Aurora Evacuator +Coag | Rebound Therapeutics | 2020-08-12 | 57 | 0 |
| K191861 | Aurora Surgiscope System | Rebound Therapeutics | 2019-12-06 | 148 | 0 |
| K190075 | Aurora Evacuator | Rebound Therapeutics | 2019-02-12 | 27 | 0 |
| K180372 | Aurora Evacuator | Rebound Therapeutics | 2018-04-09 | 56 | 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