Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Club Hearing Instruments A/S — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
95 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923292 | ITC HEARING AID CLUB MODEL LM50 | Club Hearing Instruments A/S | 1992-10-05 | 95 | 0 |
| K923296 | BTE HEARING AID CLUB MODEL ST70 | Club Hearing Instruments A/S | 1992-09-23 | 83 | 0 |
| K923294 | BTE HEARING AID CLUB MODEL: ST60 | Club Hearing Instruments A/S | 1992-09-23 | 83 | 0 |
| K923295 | ITC HEARING AID CLUB MODEL LM40 | Club Hearing Instruments A/S | 1992-09-23 | 83 | 0 |
| K923293 | ITC HEARING AID CLUB MODEL LM50H | Club Hearing Instruments A/S | 1992-09-23 | 83 | 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