Baylis Connector Cable
FDA 510(k) K254114 · Baylis Medical Technologies, Inc.
510(k) numberK254114
Submission
- Device name
- Baylis Connector Cable
- Applicant
- Baylis Medical Technologies, Inc.
Mississauga, CA - Received
- December 19, 2025
- Decision date
- January 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSA – Cable, Transducer And Electrode, Patient, (Including Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2900
- Specialty
- Cardiovascular
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| K242986 | SpO2 Extension CableDSA · Special | Beijing Rongrui-Century Science & Technology… | 05/02/2025SE |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171…DSA · Traditional | Philips Medizin Systeme Böblingen GmbH | 01/17/2025SE |
| K240087 | RT Carbon ECG LeadsDSA · Traditional | Ivy Biomedical Systems, Inc. | 09/13/2024SE |
| K240377 | LIFEPAK® ECG CablesDSA · Traditional | Stryker Physio-Control | 05/07/2024SE |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…DSA · Traditional | Physio-Control, Inc. | 04/30/2024SE |
| K222712 | Fogg System Patient Monitoring CablesDSA · Traditional | Fogg System Company, Inc. | 11/22/2023SE |
| K230571 | RFP-100A Connector Cable (Single Use)DSA · Traditional | Baylis Medical Technologies, Inc. | 05/30/2023SE |
| K222370 | SpO2 Extension CableDSA · Traditional | Beijing Rongrui-Century Science & Technology… | 04/02/2023SE |
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| K250275 | PrecisePath Radiofrequency Puncture Generator and PrecisePath FootswitchGEI · Traditional | 10/28/2025SE |
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| K232562 | PowerWire Radiofrequency Guidewire KitPDU · Traditional | 02/28/2024SESK |
| K230571 | RFP-100A Connector Cable (Single Use)DSA · Traditional | 05/30/2023SE |
Questions and answers
When was Baylis Connector Cable cleared by the FDA?
Baylis Connector Cable (K254114) received a 510(k) decision of Substantially Equivalent on January 18, 2026, 30 days after the submission was received.
What is the product code of K254114?
The FDA product code is DSA – Cable, Transducer And Electrode, Patient, (Including Connector), a Class II (moderate risk) device regulated under 21 CFR 870.2900.