FDA applicant

Baylis Medical Technologies, Inc.

Mississauga, CA5 decisions2023–20260 recalls

FDA records 5 decisions for Baylis Medical Technologies, Inc. (Mississauga, CA) from 2023 to 2026: 5 510(k) clearances. Most are in product codes DSA (Cable, Transducer And Electrode, Patient…) and PDU (Catheter For Crossing Total Occlusions). Since 2016 its 510(k)s took a median of 149 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Baylis Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2023high 2 (2025) · low 1 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Baylis Medical Technologies, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Baylis Medical Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Baylis”

FDA records each applicant name separately; these may or may not be the same firm.

Baylis Medical Co., Inc. 53

Baylis Medical Technologies, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Baylis”