Baylis Medical Company, Inc.: FDA filings under this applicant name

FDA lists 25 510(k) clearances under the applicant name “Baylis Medical Company, Inc.” (first 2012, latest 2025), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 123 days. Since 2017 the median was 154 days, against 107 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Boston Scientific, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Baylis Medical Company, Inc. took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.

Top product codes

Review panels

• Cardiovascular (17)
• General and Plastic Surgery (6)
• Neurology (1)
• Orthopedic (1)

Most recent Baylis Medical Company, Inc. 510(k) clearances

15 earlier clearances. See the full list in Caduvo.

Recalls

3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2019-10-07.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Baylis Medical Company, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT00802997: Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System (Completed, started 2008-06)
• NCT00750191: Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty (Completed, started 2007-09)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Baylis Medical Co., Inc. (28 510(k)s)
• Baylis Medical Technologies, Inc. (5 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Baylis Medical Company, Inc.?

FDA lists 25 510(k) clearances under the applicant name “Baylis Medical Company, Inc.” (first 2012, latest 2025), across 9 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Baylis Medical Company, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Baylis Medical Company, Inc. is 123 days. Since 2017: 154 days, versus 107 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Baylis Medical Company, Inc.?

The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 6); DRE (Dilator, Vessel, For Percutaneous Catheterization, 5); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 5).

Next steps

• See all 25 Baylis Medical Company, Inc. clearances with predicates and recalls
• Run predicate analysis for product code DYB, Baylis Medical Company, Inc.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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