# Baylis Medical Technologies, Inc.

- Location (FDA's records): Mississauga, CA
- FDA decisions: 5 (2023–2026): 5 510(k) clearances
- Product codes: DSA (2), PDU (2), GEI (1)
- 510(k) review time since 2016: median 149 days, against 113 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Baylis Medical Co., Inc.: 2 (https://510kreport.com/company/baylis-medical)

## Its most-cited devices
- K230571: RFP-100A Connector Cable (Single Use) (2023), cited by 1
- K232562: PowerWire Radiofrequency Guidewire Kit (2024), cited by 1

## Recent decisions
- K254114: Baylis Connector Cable (Jan 18, 2026)
- K250275: PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch (Oct 28, 2025)
- K251158: PowerWire® 14 Radiofrequency Guidewire Kit (Sep 11, 2025)
- K232562: PowerWire Radiofrequency Guidewire Kit (Feb 28, 2024)
- K230571: RFP-100A Connector Cable (Single Use) (May 30, 2023)

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