Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Novasys Medical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
134 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042132 | NOVASYS TRANSURETHRAL RF SYSTEM | Novasys Medical, Inc. | 2004-12-21 | 134 | 1 |
| K013730 | ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AN | Novasys Medical, Inc. | 2002-02-06 | 89 | 0 |
| K001328 | INTRODUCER SHEATH | Novasys Medical, Inc. | 2000-07-17 | 82 | 0 |
| K001150 | ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON | Novasys Medical, Inc. | 2000-06-29 | 80 | 0 |
| K001151 | ELECTROSURGICAL ELECTRODE FAMILY | Novasys Medical, Inc. | 2000-06-27 | 78 | 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