Baylis Medical Co., Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Baylis Medical Co., Inc.” (first 1998, latest 2013), across 12 product codes in 6 review panels. Median 510(k) review time under this name: 86 days. 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 |
|---|---|---|
| 2012 | 1 | 286 |
| 2013 | 1 | 122 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXI | Probe, Radiofrequency Lesion | 7 | 7 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| DXF | Catheter, Septostomy | 3 | 3 |
| DYB | Introducer, Catheter | 2 | 2 |
| GXD | Generator, Lesion, Radiofrequency | 2 | 2 |
| PDU | Catheter For Crossing Total Occlusions | 2 | 2 |
| DBY | Fab, Rhodamine, Antigen, Antiserum, Control | 1 | 1 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
Plus 2 more product codes.
Review panels
- Cardiovascular (10)
- Neurology (9)
- General and Plastic Surgery (6)
- General Hospital (1)
- Immunology (1)
- Orthopedic (1)
Most recent Baylis Medical Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122926 | SUREFLEX STEERABLE GUIDING SHEATH KIT | DYB | 2013-01-24 | 122 |
| K111523 | OSTEOCOOL (TM) RF ABLATION SYSTEM | GEI | 2012-03-13 | 286 |
| K102948 | TORFLEX TRANSSEPTAL GUIDING SHEATH | DYB | 2011-04-01 | 178 |
| K102192 | INDISCAL DIGITAL MANOMETER | FMF | 2011-02-23 | 203 |
| K101372 | DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 | GXI | 2010-08-10 | 85 |
| K101615 | POWERWIRE RADIOFREQUENCY GUIDEWIRE | PDU | 2010-07-28 | 49 |
| K101117 | LEV-OR DILATION CATHETER OTW | DQY | 2010-07-16 | 86 |
| K092877 | INDISCAL ASPIRATION DEVICE AND ACCESSORIES | HRX | 2009-11-17 | 60 |
| K092337 | PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS | GXI | 2009-10-16 | 73 |
| K073326 | NRG TRANSSEPTAL NEEDLE | DXF | 2008-05-28 | 183 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Baylis Medical Co., 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 Company, Inc. (25 510(k)s)
- Baylis Medical Technologies, Inc. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Baylis Medical Co., Inc.?
FDA lists 28 510(k) clearances under the applicant name “Baylis Medical Co., Inc.” (first 1998, latest 2013), across 12 product codes in 6 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 Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Baylis Medical Co., Inc. is 86 days.
Which FDA product codes appear under Baylis Medical Co., Inc.?
The most frequent FDA product codes under this applicant name are GXI (Probe, Radiofrequency Lesion, 7); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6); DXF (Catheter, Septostomy, 3).
Next steps
- See all 28 Baylis Medical Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code GXI, Baylis Medical Co., 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.