Mri Interventions, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Mri Interventions, Inc.” (first 2011, latest 2020), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 144 days. Since 2017 the median was 144 days, against 117 days for all cleared 510(k)s in the same product codes. 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 | 2 | 244 |
| 2014 | 1 | 227 |
| 2015 | 2 | 220 |
| 2016 | 2 | 48 |
| 2017 | 1 | 175 |
| 2018 | 2 | 163 |
| 2019 | 2 | 86 |
| 2020 | 1 | 30 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mri Interventions, Inc. took a median 144 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 4 | 4 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 3 | 3 |
| ORR | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri | 2 | 2 |
| GWG | Endoscope, Neurological | 1 | 1 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 1 | 1 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 1 | 1 |
| HCA | Catheter, Ventricular | 1 | 1 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 | 1 |
Review panels
Most recent Mri Interventions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200079 | ClearPoint System and Accessories | HAW | 2020-02-13 | 30 |
| K191701 | Arcus Head Fixation Frame | HBL | 2019-11-15 | 143 |
| K191400 | Voyager Trajectory Array Guide (V-TAG) | HAW | 2019-06-21 | 28 |
| K181731 | MR Compatible Aspiration Kit | GWG | 2018-11-20 | 144 |
| K181195 | ClearPoint System | ORR | 2018-11-02 | 182 |
| K171257 | ClearPoint System | ORR | 2017-10-20 | 175 |
| K160129 | MRII Cranial Drill and Accessories | HBG | 2016-03-26 | 66 |
| K160434 | ClearPoint System | HAW | 2016-03-17 | 30 |
| K142505 | ClearPoint System | HAW | 2015-10-21 | 411 |
| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | HBG | 2015-07-08 | 30 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mri Interventions, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Mri Interventions, Inc. (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mri Interventions, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Mri Interventions, Inc.” (first 2011, latest 2020), across 8 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 Mri Interventions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mri Interventions, Inc. is 144 days. Since 2017: 144 days, versus 117 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mri Interventions, Inc.?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 4); HBG (Drills, Burrs, Trephines & Accessories (Manual), 3); ORR (Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri, 2).
Next steps
- See all 14 Mri Interventions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAW, Mri Interventions, 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.