Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kindel & Anderson — 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) |
|---|---|---|---|---|---|
| K823383 | HEARING AID HB-33 RIONET | Kindel & Anderson | 1982-12-09 | 27 | 0 |
| K823384 | HEARING AID HB-72 RIONET | Kindel & Anderson | 1982-12-09 | 27 | 0 |
| K802870 | RION ELECTRO-PALATOGRAPH MODEL DP-01 | Kindel & Anderson | 1980-12-17 | 33 | 0 |
| K802812 | RIONET HEARING AID | Kindel & Anderson | 1980-11-26 | 19 | 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