Rion Acoustic Instruments, Inc.: FDA filings under this applicant name
FDA lists 51 510(k) clearances under the applicant name “Rion Acoustic Instruments, Inc.” (first 1979, latest 1988), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 28 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 47 | 47 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 2 | 2 |
| EWO | Audiometer | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ear, Nose and Throat (48)
- Neurology (2)
Most recent Rion Acoustic Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874510 | RIONET HEARING AID HB-75 | ESD | 1988-02-23 | 113 |
| K862670 | RIONET HEARING AID HB-35PT | ESD | 1986-07-31 | 17 |
| K861728 | RIONET HEARING AID | ESD | 1986-05-27 | 21 |
| K853638 | RIONET HEARING AID | ESD | 1985-09-23 | 24 |
| K853637 | RIONET HEARING AID HI-07 | ESD | 1985-09-23 | 24 |
| K853636 | RIONET HEARING AID HI-06 | ESD | 1985-09-23 | 24 |
| K852453 | RIONET HEARING AID HB-69HT | ESD | 1985-08-22 | 73 |
| K852452 | RIONET HEARING AID HB-71P | ESD | 1985-08-21 | 72 |
| K852451 | RIONET HEARING AID HB-34HT | ESD | 1985-08-21 | 72 |
| K844059 | RIONET HEARING AID HB-34AS | ESD | 1984-12-03 | 46 |
41 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Rion Acoustic Instruments, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Rion Co. Ltd. Dba Rion Acoustic Device (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rion Acoustic Instruments, Inc.?
FDA lists 51 510(k) clearances under the applicant name “Rion Acoustic Instruments, Inc.” (first 1979, latest 1988), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rion Acoustic Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rion Acoustic Instruments, Inc. is 28 days.
Which FDA product codes appear under Rion Acoustic Instruments, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 47); GWO (Plate, Cranioplasty, Preformed, Alterable, 2); EWO (Audiometer, 1).
Next steps
- See all 51 Rion Acoustic Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Rion Acoustic Instruments, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.