Rexton, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Rexton, Inc.” (first 1983, latest 1997), across 1 product code 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 |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 21 | 21 |
Review panels
- Ear, Nose and Throat (21)
Most recent Rexton, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970537 | REXTON MODEL 48 AND 49PP | ESD | 1997-03-28 | 44 |
| K964451 | PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC | ESD | 1996-11-27 | 21 |
| K960295 | LONG LIFE RX-12 | ESD | 1996-03-22 | 60 |
| K954922 | REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS | ESD | 1996-01-17 | 83 |
| K953770 | REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY | ESD | 1995-09-18 | 35 |
| K950451 | M-29 PP-PC, M-29 PP-O/PC | ESD | 1995-03-21 | 46 |
| K944851 | MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC | ESD | 1995-02-22 | 145 |
| K944777 | ORION PPM, PP, PP-D | ESD | 1994-12-30 | 94 |
| K944359 | EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12 | ESD | 1994-12-29 | 113 |
| K942702 | DEEP CANAL HEARING INSTRUMENT | ESD | 1994-12-21 | 196 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Rexton, 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 Rexton, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Rexton, Inc.” (first 1983, latest 1997), across 1 product code 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 Rexton, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rexton, Inc. is 60 days.
Which FDA product codes appear under Rexton, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 21).
Next steps
- See all 21 Rexton, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Rexton, 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.