Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KHL — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
99 daysmedian FDA review time
195 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964080 | LORI HEARING AID SIMULATOR | Lori Medical Laboratories, Inc. | 1997-01-08 | 89 | 0 |
| K911726 | PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION | Bausch & Lomb, Inc. | 1991-10-23 | 195 | 0 |
| K894019 | RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE | Resound Corp. | 1989-09-21 | 107 | 0 |
| K860171 | VOROBA PROGRAMMABLE AUDITORY COMPARATOR | Voroba Technologies Assoc. | 1986-05-02 | 105 | 0 |
| K854126 | CRAIGWELL MASTER HEARING AID MHA | Craigwell Electronics, Ltd. | 1986-01-16 | 99 | 0 |
| K802812 | RIONET HEARING AID | Kindel & Anderson | 1980-11-26 | 19 | 0 |
| K790481 | MODEL FS1 | Starkey Laboratories, Inc. | 1979-04-03 | 26 | 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