# Baylis Medical Co., Inc.

- Location (FDA's records): Mississauga, Ontario, CA
- FDA decisions: 53 (1998–2025): 53 510(k) clearances
- Names in FDA's records: Baylis Medical Co., Inc. (28); Baylis Medical Company, Inc. (24); Baylis Medical Company (1)
- Product codes: GEI (11), DYB (8), GXI (7), DRE (5), DXF (5), GXD (3), DQX (3), HRX (2), DRF (2), PDU (2), DSA (1), GAT (1)
- 510(k) review time since 2016: median 154 days, against 78 for FDA's reviews in the same codes and years (5 of 16 faster)
- Predicates its devices cite: 57 (31 its own); citations of its devices by later devices: 62 (31 its own)
- Recalls linked to its devices: 20 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Surgical Dynamics, Inc.: 5 (https://510kreport.com/company/surgical-dynamics)
- Teleflex Medical: 2 (https://510kreport.com/company/teleflex-medical)
- Dfine, Inc.: 2 (https://510kreport.com/company/dfine)
- Vascular Solutions, Inc.: 2 (https://510kreport.com/company/vascular-solutions)
- St. Jude Medical, Cardiac Rhythm Management Divisi: 1 (https://510kreport.com/company/st-jude-medical-cardiac-rhythm-management-divisi)
- Clarus Medical, LLC: 1 (https://510kreport.com/company/clarus-medical)
- AngioDynamics, Inc.: 1 (https://510kreport.com/company/angiodynamics)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)

## Firms that cite its devices most
- Stryker Instruments: 4 (https://510kreport.com/company/stryker-instruments)
- Innovative Health, LLC: 4 (https://510kreport.com/company/innovative-health)
- Diros Technology, Inc.: 3 (https://510kreport.com/company/diros-technology)
- Cross Vascular, Inc.: 2 (https://510kreport.com/company/cross-vascular)
- Baylis Medical Technologies, Inc.: 2 (https://510kreport.com/company/baylis-medical-technologies)
- Halyard Health, Inc.: 2 (https://510kreport.com/company/halyard-health)
- Medwaves Incorporated: 1 (https://510kreport.com/company/medwaves)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)

## Its most-cited devices
- K073326: NRG Transseptal Needle (2008), cited by 5
- K002389: Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector Cable/PMX-Bay-Bay (2000), cited by 4
- K053082: Baylis Pain Management Cooled Probe, Model PMPC-18-150-6 (2005), cited by 4
- K972846: BMC RF Cannula (1998), cited by 4
- K072478: Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TD (2007), cited by 3
- K122278: Baylis Medical Company Radiofrequency Perforation Generator (2012), cited by 3

## Recent decisions
- K251325: VersaCross Connect™ Transseptal Dilator (May 29, 2025)
- K242076: VersaCross™ RF Wire (Nov 1, 2024)
- K241720: VersaCross Connect™ Transseptal Dilator (Jul 12, 2024)
- K231227: SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath (Dec 20, 2023)
- K233647: VersaCross Connect™ Transseptal Dilator (Dec 14, 2023)
- K213898: ProTrack Pigtail Wire (Mar 1, 2023)
- K221351: Mechanical Guidewire (Dec 19, 2022)
- K213582: Epicardial Access System (Jun 30, 2022)

Source page: https://510kreport.com/company/baylis-medical