Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Mid-Canada Medical — Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

157 daysmedian FDA review time
441 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K933237MEDI-STIM, MODIFICATIONMid-Canada Medical1994-09-084410
K922839MID-CANADA MEDICALMid-Canada Medical1993-07-023850
K921491MEDI-STIMMid-Canada Medical1992-09-031570
K883309MULTI-CARE CHAIRMid-Canada Medical1988-09-30560
K883308PARKER BATHING SYSTEMMid-Canada Medical1988-09-22480

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