DSA · Cable, Transducer And Electrode, Patient, (Including Connector)
Cardiovascular · 21 CFR 870.2900 · Class 2
Overview
| Product Code | DSA |
|---|---|
| Device Name | Cable, Transducer And Electrode, Patient, (Including Connector) |
| Regulation | 21 CFR 870.2900 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 105)
Showing 20 most recent of 105 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254114 | Baylis Connector Cable | Baylis Medical Technologies, Inc. | Jan 18, 2026 | SESE |
| K252827 | IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) | Drägerwerk AG & Co. KGaA | Dec 1, 2025 | SESE |
| K251669 | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter | Shanghai Draeger Medical Instrument Co., Ltd. | Sep 30, 2025 | SESE |
| K242986 | SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. | May 2, 2025 | SESE |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn | Philips Medizin Systeme Böblingen GmbH | Jan 17, 2025 | SESE |
| K240087 | RT Carbon ECG Leads | Ivy Biomedical Systems, Inc. | Sep 13, 2024 | SESE |
| K240377 | LIFEPAK® ECG Cables | Stryker Physio-Control | May 7, 2024 | SESE |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) | Physio-Control, Inc. | Apr 30, 2024 | SESE |
| K222712 | Fogg System Patient Monitoring Cables | Fogg System Company, Inc. | Nov 22, 2023 | SESE |
| K230571 | RFP-100A Connector Cable (Single Use) | Baylis Medical Technologies, Inc. | May 30, 2023 | SESE |
| K222370 | SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. | Apr 2, 2023 | SESE |
| K220447 | Med-link Disposable ECG Cable and Leadwires | Shenzhen Med-Link Electronics Tech Co., Ltd. | Jun 28, 2022 | SESE |
| K211941 | 9Line | Energetic Designs, Inc. | Jan 27, 2022 | SESE |
| K211294 | Multi-Link X2 ECG Cable and Leadwire System | Vyaire Medical, Inc. | Aug 16, 2021 | SESE |
| K203556 | Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables | Medtronic, Inc. | Jul 12, 2021 | SESE |
| K200722 | PCA-C1 series Patient Cable | QT Medical, Inc. | Jun 3, 2021 | SESE |
| K203635 | Patient Monitoring Cables | Jkh USA, LLC | Feb 5, 2021 | SESE |
| K200510 | Multi-LinkTM X2 ECG Adapter and Leadwires | Vyaire Medical, Inc. | Oct 9, 2020 | SESE |
| K201359 | ECG Cables and Leadwires | Xinkang Medical Instrument Co. , Ltd. | Oct 1, 2020 | SESE |
| K200674 | AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector | Atrility Medical, LLC | Jul 2, 2020 | SESE |
Top Applicants
- Medtronic Vascular — 5 clearances
- Tronomed, Inc. — 4 clearances
- Arbo Medical, Inc. — 3 clearances
- Vyaire Medical, Inc. — 3 clearances
- Baylis Medical Technologies, Inc. — 2 clearances
