FDA applicant
Baylis Medical Co., Inc.
FDA records 53 decisions for Baylis Medical Co., Inc. (Mississauga, Ontario, CA) from 1998 to 2025: 53 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and DYB (Introducer, Catheter). Since 2016 its 510(k)s took a median of 154 days from receipt to decision, against 78 for FDA’s reviews in the same codes and years. Its devices cite 57 predicates, 31 of them its own earlier devices. 20 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Baylis Medical Company, Inc.”, “Baylis Medical Company”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Baylis Medical Co., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
3in 2025
Class I Class II/III not classified
Planning a device like Baylis Medical Co., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Baylis”
FDA records each applicant name separately; these may or may not be the same firm.