Radionics, Inc.: FDA filings under this applicant name
FDA lists 56 510(k) clearances under the applicant name “Radionics, Inc.” (first 1982, latest 2003), across 17 product codes in 6 review panels. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Integra LifeSciences, based on public ownership records.
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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 11 | 11 |
| JXG | Shunt, Central Nervous System And Components | 10 | 10 |
| IYE | Accelerator, Linear, Medical | 7 | 7 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| GXD | Generator, Lesion, Radiofrequency | 4 | 4 |
| GXI | Probe, Radiofrequency Lesion | 3 | 3 |
| GYC | Electrode, Cortical | 3 | 3 |
| MUJ | System, Planning, Radiation Therapy Treatment | 3 | 3 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| GYK | Instrument, Shunt System Implantation | 1 | 1 |
Plus 7 more product codes.
Review panels
- Neurology (34)
- Radiology (12)
- General and Plastic Surgery (7)
- Cardiovascular (1)
- Orthopedic (1)
- Physical Medicine (1)
Most recent Radionics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030697 | RADIONICS SINGLE USE GROUND PAD (DGP-HP) | GEI | 2003-04-04 | 29 |
| K002773 | NEUROMAP WITH NEURO 100 | GWF | 2000-10-23 | 47 |
| K001741 | RADIONICS RF DISC CATHETER ELECTRODE SYSTEM | HRX | 2000-10-23 | 137 |
| K992226 | XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM | JXG | 2000-08-04 | 399 |
| K001950 | OPTICAL TRACKING SYSTEM (OTS) | HAW | 2000-07-26 | 29 |
| K001700 | XPLAN 2.1 | MUJ | 2000-06-28 | 23 |
| K001431 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | HAW | 2000-05-17 | 9 |
| K000057 | RADIONICS LUMBOPERITONEAL SHUNT | JXG | 2000-03-20 | 70 |
| K993594 | CONFORMAX MMLC VR1 | IYE | 1999-12-15 | 51 |
| K991399 | RADIONICS MICROELECTRODE KIT | GXI | 1999-09-21 | 152 |
46 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-05-25.
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.
- Radionics Software Applications, Inc. (12 510(k)s)
- Radionics, A Division of Tyco Healthcare Group LP (8 510(k)s)
- Radionics Medical, Inc. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Radionics, Inc.?
FDA lists 56 510(k) clearances under the applicant name “Radionics, Inc.” (first 1982, latest 2003), across 17 product codes in 6 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 Radionics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radionics, Inc. is 84 days.
Which FDA product codes appear under Radionics, Inc.?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 11); JXG (Shunt, Central Nervous System And Components, 10); IYE (Accelerator, Linear, Medical, 7).
Next steps
- See all 56 Radionics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAW, Radionics, 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.