Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Time Medical Limited · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
208 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222259 | NEONA 1.5T MRI System | Time Medical Limited | 2023-02-21 | 208 | 0 |
| K183621 | EMMA 1.5T MRI System | Time Medical Limited | 2019-02-22 | 58 | 0 |
| K110942 | PICA WHOLE-BODY MRI SYSTEM | Time Medical Limited | 2011-07-26 | 113 | 0 |
| K093984 | PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 | Time Medical Limited | 2010-03-24 | 90 | 0 |
| K092230 | MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01 | Time Medical Limited | 2009-11-25 | 125 | 0 |
| K091580 | PICA WHOLE BODY MRI SYSTEM | Time Medical Limited | 2009-07-24 | 52 | 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