Synaptive Medical, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Synaptive Medical, Inc.” (first 2014, latest 2024), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 129 days. Since 2017 the median was 79 days, against 122 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 |
|---|---|---|
| 2014 | 1 | 112 |
| 2015 | 1 | 251 |
| 2016 | 3 | 138 |
| 2017 | 0 | — |
| 2018 | 1 | 24 |
| 2019 | 1 | 226 |
| 2020 | 1 | 79 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 20 |
| 2024 | 1 | 264 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Synaptive Medical, Inc. took a median 79 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 2 | 2 |
| IZI | System, X-Ray, Angiographic | 1 | 1 |
Review panels
Most recent Synaptive Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231986 | Modus IR | IZI | 2024-03-25 | 264 |
| K232981 | Synq Software Version 1.3 | LNH | 2023-10-11 | 20 |
| K200327 | Evry | LNH | 2020-04-29 | 79 |
| K183325 | Modus Nav | HAW | 2019-07-14 | 226 |
| K180394 | BrightMatter Plan 1.6.0 | LLZ | 2018-03-09 | 24 |
| K160523 | BrightMatter Guide with BrightMatter Pointer | HAW | 2016-06-24 | 120 |
| K153281 | BrightMatter Guide with Surface Trace Registration | HAW | 2016-03-30 | 139 |
| K153284 | Synaptive ImageDrive Pro | LLZ | 2016-03-29 | 138 |
| K142024 | BRIGHTMATTER NAVIGATION SYSTEM | HAW | 2015-04-02 | 251 |
| K140337 | BRIGHTMATTER PLANNING SOFTWARE | LLZ | 2014-06-02 | 112 |
Recalls
5 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2021-04-23.
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 Synaptive Medical, Inc. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Synaptive Medical, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Synaptive Medical, Inc.” (first 2014, latest 2024), across 4 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 Synaptive Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synaptive Medical, Inc. is 129 days. Since 2017: 79 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Synaptive Medical, Inc.?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 4); LLZ (System, Image Processing, Radiological, 3); LNH (System, Nuclear Magnetic Resonance Imaging, 2).
Next steps
- See all 10 Synaptive Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAW, Synaptive Medical, 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.