Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nats Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
235 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040143 | MONORAIL | Nats Corp. | 2004-09-13 | 235 | 0 |
| K033142 | POWERED WHEELCHAIR | Nats Corp. | 2004-05-19 | 232 | 0 |
| K020060 | ASTOFLO | Nats Corp. | 2002-03-05 | 56 | 0 |
| K011820 | DENTORIUM CONVERTIBLE ACRYLIC | Nats Corp. | 2001-09-05 | 86 | 0 |
| K991184 | HYDROTONE-THERMAL CAPSULE SYSTEM | Nats Corp. | 1999-06-23 | 76 | 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