Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Synaptive Medical, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
138 daysmedian FDA review time
264 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231986 | Modus IR | Synaptive Medical, Inc. | 2024-03-25 | 264 | 0 |
| K232981 | Synq Software Version 1.3 | Synaptive Medical, Inc. | 2023-10-11 | 20 | 0 |
| K200327 | Evry | Synaptive Medical, Inc. | 2020-04-29 | 79 | 0 |
| K183325 | Modus Nav | Synaptive Medical, Inc. | 2019-07-14 | 226 | 0 |
| K180394 | BrightMatter Plan 1.6.0 | Synaptive Medical, Inc. | 2018-03-09 | 24 | 0 |
| K160523 | BrightMatter Guide with BrightMatter Pointer | Synaptive Medical, Inc. | 2016-06-24 | 120 | 0 |
| K153281 | BrightMatter Guide with Surface Trace Registration | Synaptive Medical, Inc. | 2016-03-30 | 139 | 1 |
| K153284 | Synaptive ImageDrive Pro | Synaptive Medical, Inc. | 2016-03-29 | 138 | 0 |
| K142024 | BRIGHTMATTER NAVIGATION SYSTEM | Synaptive Medical, Inc. | 2015-04-02 | 251 | 1 |
| K140337 | BRIGHTMATTER PLANNING SOFTWARE | Synaptive Medical, Inc. | 2014-06-02 | 112 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda