Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Novoste Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
168 daysmedian FDA review time
556 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942977 | NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE | Novoste Corp. | 1995-12-28 | 556 | 0 |
| K911527 | NOVOSTE GUIDING CATHETER | Novoste Corp. | 1991-04-24 | 20 | 0 |
| K900460 | MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER | Novoste Corp. | 1990-07-17 | 168 | 0 |
| K896690 | MODIFIED ANGIOGRAPHIC CATHETER | Novoste Corp. | 1990-01-24 | 57 | 0 |
| K875127 | NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS | Novoste Corp. | 1988-08-09 | 238 | 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