Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
3nt Medical , Ltd. — 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) |
|---|---|---|---|---|---|
| K202727 | Peregrine Endoscopy System | 3nt Medical , Ltd. | 2021-07-23 | 309 | 0 |
| K192305 | Colibri Endoscopy System | 3nt Medical , Ltd. | 2020-02-27 | 188 | 0 |
| K181838 | Sinusway Dilation System | 3nt Medical , Ltd. | 2018-12-20 | 163 | 0 |
| K162916 | 3NT endoscopy system | 3nt Medical , Ltd. | 2017-02-24 | 130 | 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