Radius Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Radius Medical Technologies, Inc.” (first 1997, latest 2007), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 3 | 3 |
| MMX | Device, Percutaneous Retrieval | 3 | 3 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 | 1 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 1 | 1 |
Review panels
Most recent Radius Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070502 | RADIUS SNARE | DQY | 2007-10-04 | 225 |
| K071457 | MODIFICATION TO RADIUS SNARE | MMX | 2007-09-25 | 123 |
| K032899 | RADIUS COUGAR WIRE | DQX | 2003-10-17 | 30 |
| K032129 | RADIUS 018 COUGAR WIRE | DQX | 2003-07-17 | 7 |
| K022201 | RADIUS MICRO SNARE | MMX | 2003-02-03 | 213 |
| K021441 | RADIUS SNARE | MMX | 2002-06-14 | 39 |
| K011759 | RADIUS NEXT GENERATION GUIDEWIRE | OCY | 2001-08-23 | 78 |
| K011287 | RADIUS COUGAR WIRE | DQX | 2001-05-25 | 28 |
| K970466 | RADIUS PTCA GUIDEWIRE | LIT | 1997-05-20 | 102 |
Recalls
openFDA lists no recalls under a recalling firm named Radius Medical Technologies, 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 Intl., Inc. (5 510(k)s)
- Radius Medical, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Radius Medical Technologies, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Radius Medical Technologies, Inc.” (first 1997, latest 2007), across 5 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 Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radius Medical Technologies, Inc. is 78 days.
Which FDA product codes appear under Radius Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 3); MMX (Device, Percutaneous Retrieval, 3); DQY (Catheter, Percutaneous, 1).
Next steps
- See all 9 Radius Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Radius Medical Technologies, 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.