Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Amplus Corp. — 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) |
|---|---|---|---|---|---|
| K903066 | AMPLAID 770 ADMITTANCE METER | Amplus Corp. | 1990-10-24 | 104 | 0 |
| K891988 | AMPLAID A308 CLINICAL AUDIOMETER | Amplus Corp. | 1989-10-12 | 198 | 0 |
| K884071 | AMPLAID EMG15 | Amplus Corp. | 1989-02-27 | 153 | 0 |
| K880059 | AMPLAID 309 CLINICAL AUDIOMETER | Amplus Corp. | 1988-02-23 | 47 | 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