Radius Intl., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Radius Intl., Inc.” (first 1995, latest 1998), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 235 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 3 | 3 |
| BSS | Tube, Nasogastric | 1 | 1 |
| IOR | Wheelchair, Mechanical | 1 | 1 |
Review panels
Most recent Radius Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972102 | RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT | KNT | 1998-01-23 | 233 |
| K972025 | RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT | KNT | 1998-01-23 | 235 |
| K971901 | RADIUS LOW PROFILE GASTROSTOMY TUBE KIT | KNT | 1998-01-22 | 244 |
| K951560 | RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS) | IOR | 1995-04-17 | 12 |
| K930510 | RADIUS ENTERAL FEEDING TUBE | BSS | 1995-02-01 | 730 |
Recalls
openFDA lists no recalls under a recalling firm named Radius Intl., 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.
- Radius Medical Technologies, Inc. (9 510(k)s)
- Radius Medical, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Radius Intl., Inc.?
FDA lists 5 510(k) clearances under the applicant name “Radius Intl., Inc.” (first 1995, latest 1998), 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 Radius Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radius Intl., Inc. is 235 days.
Which FDA product codes appear under Radius Intl., Inc.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 3); BSS (Tube, Nasogastric, 1); IOR (Wheelchair, Mechanical, 1).
Next steps
- See all 5 Radius Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Radius Intl., 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.