Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nitiloop , 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) |
|---|---|---|---|---|---|
| K193322 | NovaCross CTO Microcatheter | Nitiloop , Ltd. | 2020-04-02 | 122 | 0 |
| K172297 | NovaCross Microcatheter | Nitiloop , Ltd. | 2017-10-18 | 79 | 0 |
| K160389 | NovaCross Microcatheter | Nitiloop , Ltd. | 2016-03-11 | 29 | 0 |
| K143608 | NovaCross Microcatheter | Nitiloop , Ltd. | 2015-05-04 | 136 | 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