Precision Acoustics Ind., Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Precision Acoustics Ind., Inc.” (first 1993, latest 1994), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| EWO | Audiometer | 5 | 5 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 2 | 2 |
| ETY | Tester, Auditory Impedance | 2 | 2 |
Review panels
Most recent Precision Acoustics Ind., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943607 | INTERACOUSTICS HEARING AID ANALYZER MS 40 | ETW | 1994-09-23 | 60 |
| K941920 | INTERACOUSTICS CLINICAL AUDIOMETER | EWO | 1994-09-16 | 149 |
| K943066 | INTERACOUSTICS COMPUTER AUDIOMETER BA 20 | EWO | 1994-08-24 | 57 |
| K942008 | INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER | ETY | 1994-08-24 | 121 |
| K942007 | INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26 | ETY | 1994-08-24 | 121 |
| K943065 | INTERACOUSTICS CLINICAL AUDIOMETER | EWO | 1994-08-17 | 50 |
| K942006 | INTERACOUSTICS DIAGNOSTIC AUDIOMETER | EWO | 1994-06-20 | 56 |
| K941848 | INTERACOUSTICS. HEARING AID ANALYZER | ETW | 1994-05-23 | 39 |
| K930260 | ACOUSTIC ANALYZER AA30 | EWO | 1993-07-13 | 175 |
Recalls
openFDA lists no recalls under a recalling firm named Precision Acoustics Ind., 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.
- Precision Medical, Inc. (30 510(k)s)
- Precision Dynamics Corp. (26 510(k)s)
- Precision Spine, Inc. (26 510(k)s)
- Precision Biologicals, Inc. (20 510(k)s)
- Precision Biologic (17 510(k)s)
- Precision Med Products, Ltd. (16 510(k)s)
- Precision Cap Systems (7 510(k)s)
- Precision Vascular Systems, Inc. (7 510(k)s)
- Precision Instruments, Inc. (4 510(k)s)
- Precision Laser Products, Inc. (4 510(k)s)
- Precision Medical Instruments, Inc. (4 510(k)s)
- Precision Therapy Intl., Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Precision Acoustics Ind., Inc.?
FDA lists 9 510(k) clearances under the applicant name “Precision Acoustics Ind., Inc.” (first 1993, latest 1994), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Precision Acoustics Ind., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Precision Acoustics Ind., Inc. is 60 days.
Which FDA product codes appear under Precision Acoustics Ind., Inc.?
The most frequent FDA product codes under this applicant name are EWO (Audiometer, 5); ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems, 2); ETY (Tester, Auditory Impedance, 2).
Next steps
- See all 9 Precision Acoustics Ind., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EWO, Precision Acoustics Ind., 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.