Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Novosci Corp. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063355 | D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW | Novosci Corp. | 2007-07-27 | 262 | 0 |
| K033270 | NOVOSCI READY SYSTEM, MODEL RS-200 | Novosci Corp. | 2004-02-13 | 126 | 0 |
| K033328 | NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT | Novosci Corp. | 2004-01-16 | 92 | 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