Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hc Electronics — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
14 daysmedian FDA review time
57 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K810031 | STEREO AUDITORY TRAINER (MODEL PM228) | Hc Electronics | 1981-03-04 | 57 | 0 |
| K810030 | POST-AURICULAR HEARING AID (#PE830) | Hc Electronics | 1981-01-14 | 8 | 0 |
| K800340 | PHONIC EAR, MODEL 841L | Hc Electronics | 1980-02-26 | 11 | 0 |
| K782053 | HEARING AID, POST-AURICULAR | Hc Electronics | 1978-12-15 | 8 | 0 |
| K780936 | PHONIC EAR | Hc Electronics | 1978-06-22 | 14 | 0 |
| K780363 | PHONIC EAR | Hc Electronics | 1978-03-21 | 15 | 0 |
| K772346 | PHONIC MIRROR HANDIVOCIE MODEL 110 | Hc Electronics | 1978-01-11 | 19 | 0 |
| K772347 | PHONIC MIRROR HANDIVOICE MODEL 120 | Hc Electronics | 1978-01-11 | 19 | 0 |
| K771357 | GROUP AUDITORY TRAINER HC 431R | Hc Electronics | 1977-07-29 | 7 | 0 |
| K771356 | POST-AURICULAR HEARING AID HC 880 | Hc Electronics | 1977-07-29 | 7 | 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