Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Authorized Hearing Systems, Inc. — Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
71 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971693 | RIONET HB-79P | Authorized Hearing Systems, Inc. | 1997-06-06 | 30 | 0 |
| K970057 | AHS OMEGA SP | Authorized Hearing Systems, Inc. | 1997-02-26 | 50 | 0 |
| K963878 | AHS OMEGA HF | Authorized Hearing Systems, Inc. | 1996-12-06 | 71 | 0 |
| K963877 | AHS OMEGA CONCEPT | Authorized Hearing Systems, Inc. | 1996-12-06 | 71 | 0 |
| K963875 | AHS OMEGA K-AMP | Authorized Hearing Systems, Inc. | 1996-11-27 | 62 | 0 |
| K963873 | AHS OMEGA DEQ | Authorized Hearing Systems, Inc. | 1996-11-26 | 61 | 0 |
| K963879 | AHS DELTA 22 | Authorized Hearing Systems, Inc. | 1996-11-26 | 61 | 0 |
| K963876 | AHS OMEGA PP | Authorized Hearing Systems, Inc. | 1996-11-26 | 61 | 0 |
| K963881 | AHS DELTA 22 T | Authorized Hearing Systems, Inc. | 1996-11-26 | 61 | 0 |
| K963874 | AHS OMEGA AGC | Authorized Hearing Systems, Inc. | 1996-11-26 | 61 | 0 |
| K963153 | RIONET HB-55S | Authorized Hearing Systems, Inc. | 1996-09-05 | 23 | 0 |
| K963154 | RIONET HB-54AS | Authorized Hearing Systems, Inc. | 1996-09-05 | 22 | 0 |
| K963152 | RIONET HB-55AS | Authorized Hearing Systems, Inc. | 1996-09-05 | 23 | 0 |
| K961907 | RIONET HEARING AID HB53-K | Authorized Hearing Systems, Inc. | 1996-07-03 | 48 | 0 |
| K951677 | RIONET HEARING AID HM-02 | Authorized Hearing Systems, Inc. | 1995-06-02 | 52 | 0 |
| K944161 | IMAGE | Authorized Hearing Systems, Inc. | 1994-12-21 | 117 | 0 |
| K941140 | RIONET HEARING AID HB-37T | Authorized Hearing Systems, Inc. | 1994-05-04 | 55 | 0 |
| K941021 | RIONET HEARING AID HB-54 | Authorized Hearing Systems, Inc. | 1994-05-04 | 62 | 0 |
| K936122 | RIONET HEARING AID HB-53CI | Authorized Hearing Systems, Inc. | 1994-03-21 | 88 | 0 |
| K934479 | RIONET HEARING AID HA-72 | Authorized Hearing Systems, Inc. | 1993-11-19 | 70 | 0 |
| K934480 | RIONET HEARING AID HA-73 | Authorized Hearing Systems, Inc. | 1993-11-19 | 70 | 0 |
| K930721 | RIONET HEARING AID HB-53S | Authorized Hearing Systems, Inc. | 1993-04-07 | 55 | 0 |
| K923801 | RIONET HB75-AL BTE AID | Authorized Hearing Systems, Inc. | 1992-09-28 | 61 | 0 |
| K921829 | RIONET HEARING AID HB-52S | Authorized Hearing Systems, Inc. | 1992-04-29 | 13 | 0 |
| K921830 | RIONET HEARING AID HB-52T | Authorized Hearing Systems, Inc. | 1992-04-28 | 12 | 0 |
| K920897 | RIONET HEARING AID - HB 52DU | Authorized Hearing Systems, Inc. | 1992-03-19 | 22 | 0 |
| K920522 | RIONET HEARING AID HB-23M | Authorized Hearing Systems, Inc. | 1992-02-19 | 15 | 0 |
| K920521 | RIONET HEARING AID HB-23T | Authorized Hearing Systems, Inc. | 1992-02-19 | 15 | 0 |
| K920486 | RIONET HEARING AID HB-53P | Authorized Hearing Systems, Inc. | 1992-02-14 | 15 | 0 |
| K915875 | RIONET HEARING AID HB-71K (K-AMP) | Authorized Hearing Systems, Inc. | 1992-01-13 | 25 | 0 |
| K862169 | ALPHA ALL-IN-THE-EAR HEARING AID | Authorized Hearing Systems, Inc. | 1986-07-22 | 43 | 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