Unitron Industries, Inc.: FDA clearances and approvals
Unitron Industries, Inc. has 69 FDA 510(k) clearances (first 1976, latest 1997), across 1 product code in 1 review panel. Median 510(k) review time: 28 days.
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 | 69 | 69 |
Review panels
- Ear, Nose and Throat (69)
Most recent Unitron Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974340 | UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE | ESD | 1997-12-12 | 24 |
| K974339 | UNITRON MODEL SOUND F/XD PROGRAMMABLE | ESD | 1997-12-12 | 24 |
| K974338 | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) | ESD | 1997-12-12 | 24 |
| K970692 | UNITRON MODEL SOUND F/X CIC | ESD | 1997-05-08 | 72 |
| K970519 | UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) | ESD | 1997-04-24 | 72 |
| K964511 | UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) | ESD | 1996-11-27 | 19 |
| K964510 | UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) | ESD | 1996-11-27 | 19 |
| K964508 | UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) | ESD | 1996-11-27 | 19 |
| K964504 | UNITRON MODEL ICON AOHPL +4 | ESD | 1996-11-27 | 19 |
| K964503 | UNITRON MODEL SOUND F/X +4 | ESD | 1996-11-27 | 19 |
59 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Unitron Industries, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Unitron Industries, Inc. have?
Unitron Industries, Inc. has 69 FDA 510(k) clearances (first 1976, latest 1997), across 1 product code in 1 review panel.
How long does FDA take to clear Unitron Industries, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Unitron Industries, Inc.'s cleared 510(k)s is 28 days.
What devices does Unitron Industries, Inc. make?
Its most frequent FDA product codes are ESD (Hearing Aid, Air-Conduction, Prescription, 69).
Has Unitron Industries, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Unitron Industries, Inc. Related entities may recall under other names.
Next steps
- See all 69 Unitron Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Unitron Industries, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.