Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Interscope, 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) |
|---|---|---|---|---|---|
| DEN200016 | EndoRotor Device | Interscope, Inc. | 2020-12-23 | 282 | 0 |
| K190715 | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Tr | Interscope, Inc. | 2019-12-13 | 269 | 0 |
| K181127 | EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen T | Interscope, Inc. | 2019-01-03 | 248 | 0 |
| K170120 | EndoRotor | Interscope, Inc. | 2017-04-18 | 95 | 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