Rastronics USA, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Rastronics USA, Inc.” (first 1985, latest 1990), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 114 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 |
|---|---|---|---|
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 3 | 3 |
| EJT | Alloy, Gold-Based Noble Metal | 1 | 1 |
| ETY | Tester, Auditory Impedance | 1 | 1 |
Review panels
- Ear, Nose and Throat (4)
- Dental (1)
Most recent Rastronics USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902244 | RASTRONICS CCI 8 | ETW | 1990-10-05 | 140 |
| K902252 | RASTRONICS CCI 10/3 HEARING AID ANALYSIS | ETW | 1990-09-12 | 114 |
| K902287 | RASTRONICS PORTAREM 20 | EJT | 1990-08-09 | 79 |
| K890864 | HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS. | ETY | 1989-06-21 | 120 |
| K853320 | FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10 | ETW | 1985-09-27 | 59 |
Recalls
openFDA lists no recalls under a recalling firm named Rastronics USA, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Rastronics USA, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Rastronics USA, Inc.” (first 1985, latest 1990), across 3 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 Rastronics USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rastronics USA, Inc. is 114 days.
Which FDA product codes appear under Rastronics USA, Inc.?
The most frequent FDA product codes under this applicant name are ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems, 3); EJT (Alloy, Gold-Based Noble Metal, 1); ETY (Tester, Auditory Impedance, 1).
Next steps
- See all 5 Rastronics USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ETW, Rastronics USA, 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.