Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Perfect Ear — 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) |
|---|---|---|---|---|---|
| K973972 | PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C | Perfect Ear | 1997-11-04 | 15 | 0 |
| K960410 | PERFECT EAR PE/PE-AGC/PE-B/PE-PWR | Perfect Ear | 1996-04-04 | 66 | 0 |
| K931984 | PERFECT EAR/PE | Perfect Ear | 1993-06-08 | 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