Baylis Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Baylis Medical Technologies, Inc.” (first 2023, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 149 days. Since 2017 the median was 149 days, against 113 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
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 90 |
| 2024 | 1 | 188 |
| 2025 | 2 | 210 |
| 2026 | 1 | 30 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Baylis Medical Technologies, Inc. took a median 149 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 2 | 2 |
| PDU | Catheter For Crossing Total Occlusions | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Baylis Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254114 | Baylis Connector Cable | DSA | 2026-01-18 | 30 |
| K250275 | PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch | GEI | 2025-10-28 | 270 |
| K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | PDU | 2025-09-11 | 149 |
| K232562 | PowerWire Radiofrequency Guidewire Kit | PDU | 2024-02-28 | 188 |
| K230571 | RFP-100A Connector Cable (Single Use) | DSA | 2023-05-30 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Baylis Medical Technologies, Inc..
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.
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 Company, Inc. (25 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Baylis Medical Technologies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Baylis Medical Technologies, Inc.” (first 2023, latest 2026), across 3 product codes in 2 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 Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Baylis Medical Technologies, Inc. is 149 days. Since 2017: 149 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Baylis Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 2); PDU (Catheter For Crossing Total Occlusions, 2); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 5 Baylis Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSA, Baylis Medical Technologies, 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.