Redman, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Redman, Inc.” (first 1987, latest 1995), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 21 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 |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | 6 | 6 |
| ITI | Wheelchair, Powered | 6 | 6 |
| IPL | Wheelchair, Standup | 2 | 2 |
| KNN | Components, Wheelchair | 1 | 1 |
| KNO | Accessories, Wheelchair | 1 | 1 |
Review panels
- Physical Medicine (16)
Most recent Redman, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940920 | ROAD SAVAGE | ITI | 1995-02-03 | 343 |
| K940919 | CHIEF SR | IPL | 1995-02-03 | 344 |
| K940852 | CHIEF STANDUP WHEELCHAIR | IPL | 1995-02-03 | 345 |
| K940851 | RED PACK MANLUAL POWER WHEELCHAIR CONVERSION KIT | ITI | 1995-02-03 | 345 |
| K935751 | GERONIMO PR | ITI | 1995-02-03 | 434 |
| K935750 | GERONIMO | ITI | 1995-02-03 | 434 |
| K935749 | ROAD WARRIOR | ITI | 1995-01-13 | 413 |
| K870298 | REDMAN ACCESSORIES | KNO | 1987-02-26 | 29 |
| K870299 | REDMAN UPHOLSTERY SERIES FOR WHEELCHAIRS | KNN | 1987-02-10 | 13 |
| K870297 | DAKOTA MODEL 102C WHEELCHAIR | ITI | 1987-02-10 | 13 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Redman, 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 Redman, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Redman, Inc.” (first 1987, latest 1995), across 5 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 Redman, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Redman, Inc. is 21 days.
Which FDA product codes appear under Redman, Inc.?
The most frequent FDA product codes under this applicant name are IOR (Wheelchair, Mechanical, 6); ITI (Wheelchair, Powered, 6); IPL (Wheelchair, Standup, 2).
Next steps
- See all 16 Redman, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IOR, Redman, 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.