DSA · Class II · 21 CFR 870.2900

FDA Product Code DSA: Cable, Transducer And Electrode, Patient, (including Connector)

Leading manufacturers include Medtronic Vascular, Vyaire Medical, Inc. and Conmedcorp.

105
Total
105
Cleared
123d
Avg days
1977
Since
Stable submission activity - 6 submissions in the last 2 years
Consistent review times: 128d avg (recent)

FDA 510(k) Cleared Cable, Transducer And Electrode, Patient, (including Connector) Devices (Product Code DSA)

105 devices
1–24 of 105
Cleared Jan 18, 2026
Baylis Connector Cable
K254114
Baylis Medical Technologies, Inc.
Cardiovascular · 30d
Cleared Dec 01, 2025
IBP cable Becton Dickinson (2606488)
K252827
Dr?gerwerk AG & Co KGaA
Cardiovascular · 87d
Cleared Sep 30, 2025
IBP transducer adapter cable, Argon/BD/Ohmeda, 2m
K251669
Shanghai Draeger Medical Instrument Co., Ltd.
Cardiovascular · 123d
Cleared May 02, 2025
SpO2 Extension Cable
K242986
Beijing Rongrui-Century Science & Technology Co., Ltd.
Anesthesiology · 218d
Cleared Jan 17, 2025
Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC
K243545
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 63d
Cleared Sep 13, 2024
RT Carbon ECG Leads
K240087
Ivy Biomedical Systems, Inc.
Cardiovascular · 246d
Cleared May 07, 2024
LIFEPAK® ECG Cables
K240377
Stryker Physio-Control
Cardiovascular · 90d
Cleared Apr 30, 2024
LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021)
K240156
Physio-Control, Inc.
Cardiovascular · 102d
Cleared Nov 22, 2023
Fogg System Patient Monitoring Cables
K222712
Fogg System Company, Inc.
Cardiovascular · 440d
Cleared May 30, 2023
RFP-100A Connector Cable (Single Use)
K230571
Baylis Medical Technologies, Inc.
Cardiovascular · 90d
Cleared Apr 02, 2023
SpO2 Extension Cable
K222370
Beijing Rongrui-Century Science & Technology Co., Ltd.
Anesthesiology · 240d
Cleared Jun 28, 2022
Med-link Disposable ECG Cable and Leadwires
K220447
Shenzhen Med-Link Electronics Tech Co., Ltd.
Cardiovascular · 132d
Cleared Jan 27, 2022
9Line
K211941
Energetic Designs, Inc.
Cardiovascular · 218d
Cleared Aug 16, 2021
Multi-Link X2 ECG Cable and Leadwire System
K211294
Vyaire Medical, Inc.
Cardiovascular · 110d
Cleared Jul 12, 2021
Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
K203556
Medtronic, Inc.
Cardiovascular · 217d
Cleared Jun 03, 2021
PCA-C1 series Patient Cable
K200722
QT Medical, Inc.
Cardiovascular · 441d
Cleared Feb 05, 2021
Patient Monitoring Cables
K203635
Jkh USA, LLC
Cardiovascular · 53d
Cleared Oct 09, 2020
Multi-LinkTM X2 ECG Adapter and Leadwires
K200510
Vyaire Medical, Inc.
Cardiovascular · 221d
Cleared Oct 01, 2020
ECG Cables and Leadwires
K201359
Xinkang Medical Instrument Co. , Ltd.
Cardiovascular · 133d
Cleared Jul 02, 2020
AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector
K200674
Atrility Medical, LLC
Cardiovascular · 108d
Cleared Jun 22, 2020
Patient Monitoring Cable (SpO2 Extension Cable)
K192404
Shenzhen Coreray Technology, Ltd.
Anesthesiology · 293d
Cleared May 12, 2020
Disposable ECG Cable
K200026
Shenzhen Changke Connect Electronics Co., Ltd.
Cardiovascular · 127d
Cleared Jan 17, 2020
SureLead Cable System
K181089
Authentic Medical
Cardiovascular · 632d
Cleared Nov 27, 2019
ECG Cable
K191428
Shenzhen Changke Connect Electronics Co., Ltd.
Cardiovascular · 182d

About Product Code DSA - Regulatory Context

510(k) Submission Activity

105 total 510(k) submissions under product code DSA since 1977, with 105 receiving FDA clearance (average review time: 123 days).

Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.

FDA 510(k) Review Time - DSA Product Code

FDA review times for DSA submissions have been consistent, averaging 128 days recently vs 123 days historically.

DSA devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →