Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rion Acoustic Instruments, Inc. — Predicate Candidate Screening
51 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
66 days90th percentile
51clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K874510 | RIONET HEARING AID HB-75 | Rion Acoustic Instruments, Inc. | 1988-02-23 | 113 | 0 |
| K862670 | RIONET HEARING AID HB-35PT | Rion Acoustic Instruments, Inc. | 1986-07-31 | 17 | 0 |
| K861728 | RIONET HEARING AID | Rion Acoustic Instruments, Inc. | 1986-05-27 | 21 | 0 |
| K853636 | RIONET HEARING AID HI-06 | Rion Acoustic Instruments, Inc. | 1985-09-23 | 24 | 0 |
| K853638 | RIONET HEARING AID | Rion Acoustic Instruments, Inc. | 1985-09-23 | 24 | 0 |
| K853637 | RIONET HEARING AID HI-07 | Rion Acoustic Instruments, Inc. | 1985-09-23 | 24 | 0 |
| K852453 | RIONET HEARING AID HB-69HT | Rion Acoustic Instruments, Inc. | 1985-08-22 | 73 | 0 |
| K852452 | RIONET HEARING AID HB-71P | Rion Acoustic Instruments, Inc. | 1985-08-21 | 72 | 0 |
| K852451 | RIONET HEARING AID HB-34HT | Rion Acoustic Instruments, Inc. | 1985-08-21 | 72 | 0 |
| K844059 | RIONET HEARING AID HB-34AS | Rion Acoustic Instruments, Inc. | 1984-12-03 | 46 | 0 |
| K844000 | RIONET HEARING AID HB-73 | Rion Acoustic Instruments, Inc. | 1984-11-09 | 28 | 0 |
| K842875 | RIONET HEARING AID HB-35 | Rion Acoustic Instruments, Inc. | 1984-08-24 | 32 | 0 |
| K841935 | RIONET HEARING AID HI-03 | Rion Acoustic Instruments, Inc. | 1984-08-14 | 95 | 0 |
| K841012 | RIONET HEARING AID HB-71M | Rion Acoustic Instruments, Inc. | 1984-03-30 | 21 | 0 |
| K833926 | HEARING AID | Rion Acoustic Instruments, Inc. | 1983-12-19 | 35 | 0 |
| K833134 | RIONET HEARING AID HB-345 | Rion Acoustic Instruments, Inc. | 1983-11-14 | 62 | 0 |
| K831721 | RIONET HEARING AID -AND/OR RION | Rion Acoustic Instruments, Inc. | 1983-07-07 | 37 | 0 |
| K830236 | RIONET HEARING AID | Rion Acoustic Instruments, Inc. | 1983-03-24 | 58 | 0 |
| K823847 | RIONET HEARING AID HB-69CI | Rion Acoustic Instruments, Inc. | 1983-01-21 | 31 | 0 |
| K823803 | RIONET HEARING AID HB-32P | Rion Acoustic Instruments, Inc. | 1983-01-21 | 35 | 0 |
| K821508 | RIONET HEARING AID | Rion Acoustic Instruments, Inc. | 1982-06-09 | 19 | 0 |
| K820656 | RIONET HEARING AID HA-57 | Rion Acoustic Instruments, Inc. | 1982-04-09 | 31 | 0 |
| K820350 | RIONET HEARING AID HB-71S | Rion Acoustic Instruments, Inc. | 1982-03-01 | 21 | 0 |
| K820348 | RIONET HEARING AID HB-69AS | Rion Acoustic Instruments, Inc. | 1982-03-01 | 21 | 0 |
| K820349 | RIONET HEARING AID HB-71H | Rion Acoustic Instruments, Inc. | 1982-03-01 | 21 | 0 |
| K813546 | RIONET HEARING AID HI-62 | Rion Acoustic Instruments, Inc. | 1982-01-12 | 22 | 0 |
| K812951 | RION AUDIOMETER AA-67 | Rion Acoustic Instruments, Inc. | 1981-11-06 | 16 | 0 |
| K812952 | RION AUDIOMETER AA-68 | Rion Acoustic Instruments, Inc. | 1981-11-06 | 16 | 0 |
| K811531 | RIONET HEARING AID HB-69 | Rion Acoustic Instruments, Inc. | 1981-06-26 | 25 | 0 |
| K811530 | RIONET HEARING AID HB 69 T | Rion Acoustic Instruments, Inc. | 1981-06-26 | 25 | 0 |
| K811529 | RIONET HEARING AID HB-69S | Rion Acoustic Instruments, Inc. | 1981-06-26 | 25 | 0 |
| K802053 | RIONET HEARING AID HB-69C | Rion Acoustic Instruments, Inc. | 1980-09-26 | 32 | 0 |
| K802207 | RION DIAGNOSTIC AUDIOMETER | Rion Acoustic Instruments, Inc. | 1980-09-26 | 15 | 0 |
| K801958 | RIONET HEARING AID HB-70H | Rion Acoustic Instruments, Inc. | 1980-09-09 | 48 | 0 |
| K801692 | RIONET HEARING AID AND/OR RION #HB-70 | Rion Acoustic Instruments, Inc. | 1980-08-14 | 22 | 0 |
| K801556 | RIONET HEARING AID HB-66 | Rion Acoustic Instruments, Inc. | 1980-07-28 | 20 | 0 |
| K800739 | RIONET &/OR RION HEARING AID MODEL HA-82 | Rion Acoustic Instruments, Inc. | 1980-04-24 | 22 | 0 |
| K800738 | RIONET &/OR RION HEARING AID MOD. HB-67S | Rion Acoustic Instruments, Inc. | 1980-04-24 | 22 | 0 |
| K800012 | RIONET HEARING AID HA-61 | Rion Acoustic Instruments, Inc. | 1980-01-29 | 25 | 0 |
| K800011 | RIONET HEARING AID HE-71 | Rion Acoustic Instruments, Inc. | 1980-01-29 | 25 | 0 |
| K792506 | RIONET HEARING AID HB-68L | Rion Acoustic Instruments, Inc. | 1979-12-27 | 23 | 0 |
| K792505 | RIONET HEARING AID HB-32T | Rion Acoustic Instruments, Inc. | 1979-12-27 | 23 | 0 |
| K791878 | RIONET HEARING AID HB-64C | Rion Acoustic Instruments, Inc. | 1979-11-05 | 66 | 0 |
| K791739 | RIONET HEARING AID MODEL HA-55 | Rion Acoustic Instruments, Inc. | 1979-11-05 | 66 | 0 |
| K791881 | RIONET HEARING AID HB-65T | Rion Acoustic Instruments, Inc. | 1979-11-05 | 66 | 0 |
| K791880 | RIONET HEARING AID HB-64T | Rion Acoustic Instruments, Inc. | 1979-11-05 | 66 | 0 |
| K791876 | RIONET HEARING AID HB-32 | Rion Acoustic Instruments, Inc. | 1979-10-30 | 60 | 0 |
| K791877 | RIONET HEARING AID HB-32H | Rion Acoustic Instruments, Inc. | 1979-10-30 | 60 | 0 |
| K791884 | RIONET HEARING AID HI-60 | Rion Acoustic Instruments, Inc. | 1979-10-30 | 60 | 0 |
| K791882 | RIONET HEARING AID HB-67T | Rion Acoustic Instruments, Inc. | 1979-10-30 | 60 | 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