Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Toronto Medical Corp. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
265 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950682 | W2 WRIST CPM UNIT | Toronto Medical Corp. | 1995-09-13 | 211 | 0 |
| K935587 | MULTILINK SHOULDER CPM UNIT | Toronto Medical Corp. | 1994-12-14 | 393 | 0 |
| K935841 | DR KOOL | Toronto Medical Corp. | 1994-08-29 | 265 | 0 |
| K925926 | MOBILIMB T1 TOE CPM UNIT | Toronto Medical Corp. | 1993-03-22 | 119 | 0 |
| K900795 | MOBILIMB L4 LOWER LIMB CPM UNIT | Toronto Medical Corp. | 1990-03-12 | 20 | 0 |
| K900466 | MOBILIMB W1 WRIST CPM UNIT | Toronto Medical Corp. | 1990-03-12 | 40 | 0 |
| K900794 | MOBILIMB H3 HAND CPM UNIT | Toronto Medical Corp. | 1990-03-02 | 10 | 0 |
| K895720 | MOBILIMB J1 TMJ CPM UNIT | Toronto Medical Corp. | 1990-01-04 | 101 | 0 |
| K891345 | MOBILIMB CPM SHOULDER UNIT | Toronto Medical Corp. | 1989-04-24 | 46 | 0 |
| K880686 | TORONTO/MOBILIMB HAND C.P.M. | Toronto Medical Corp. | 1988-02-26 | 7 | 0 |
| K880336 | MOBILIMB HAND C.P.M. UNIT | Toronto Medical Corp. | 1988-02-16 | 21 | 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