Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Syntheticmr AB — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
352 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203372 | SyMRI | Syntheticmr AB | 2021-11-03 | 352 | 0 |
| K201616 | SyMRI | Syntheticmr AB | 2020-07-28 | 43 | 0 |
| K191036 | SyMRI | Syntheticmr AB | 2019-06-13 | 56 | 0 |
| K181093 | SyMRI | Syntheticmr AB | 2018-06-12 | 48 | 0 |
| K173558 | SyMRI | Syntheticmr AB | 2018-01-26 | 70 | 0 |
| K162943 | SyMRI | Syntheticmr AB | 2017-08-29 | 312 | 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