FDA Product Code DSA: Cable, Transducer And Electrode, Patient, (including Connector)
Leading manufacturers include Medtronic Vascular, Vyaire Medical, Inc. and Baylis Medical Technologies, Inc..
105
Total
105
Cleared
123d
Avg days
1977
Since
Stable submission activity - 5 submissions in the last 2 years
Review times improving: avg
104d
recently vs 124d historically
FDA 510(k) Cleared Cable, Transducer And Electrode, Patient, (including Connector) Devices (Product Code DSA)
105 devices
Cleared
Jan 18, 2026
Baylis Connector Cable
Baylis Medical Technologies, Inc.
Cardiovascular
30d
Cleared
Dec 01, 2025
IBP cable Becton Dickinson (2606488)
Dr?gerwerk AG & Co KGaA
Cardiovascular
87d
Cleared
Sep 30, 2025
IBP transducer adapter cable, Argon/BD/Ohmeda, 2m
Shanghai Draeger Medical Instrument Co., Ltd.
Cardiovascular
123d
Cleared
May 02, 2025
SpO2 Extension Cable
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
Philips Medizin Systeme B?blingen GmbH
Cardiovascular
63d
Cleared
Sep 13, 2024
RT Carbon ECG Leads
Ivy Biomedical Systems, Inc.
Cardiovascular
246d
Cleared
May 07, 2024
LIFEPAK® ECG Cables
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)
Physio-Control, Inc.
Cardiovascular
102d
Cleared
Nov 22, 2023
Fogg System Patient Monitoring Cables
Fogg System Company, Inc.
Cardiovascular
440d
Cleared
May 30, 2023
RFP-100A Connector Cable (Single Use)
Baylis Medical Technologies, Inc.
Cardiovascular
90d
Cleared
Apr 02, 2023
SpO2 Extension Cable
Beijing Rongrui-Century Science & Technology Co., Ltd.
Anesthesiology
240d
Cleared
Jun 28, 2022
Med-link Disposable ECG Cable and Leadwires
Shenzhen Med-Link Electronics Tech Co., Ltd.
Cardiovascular
132d
Cleared
Jan 27, 2022
9Line
Energetic Designs, Inc.
Cardiovascular
218d
Cleared
Aug 16, 2021
Multi-Link X2 ECG Cable and Leadwire System
Vyaire Medical, Inc.
Cardiovascular
110d
Cleared
Jul 12, 2021
Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
Medtronic, Inc.
Cardiovascular
217d
Cleared
Jun 03, 2021
PCA-C1 series Patient Cable
QT Medical, Inc.
Cardiovascular
441d
Cleared
Feb 05, 2021
Patient Monitoring Cables
Jkh USA, LLC
Cardiovascular
53d
Cleared
Oct 09, 2020
Multi-LinkTM X2 ECG Adapter and Leadwires
Vyaire Medical, Inc.
Cardiovascular
221d
Cleared
Oct 01, 2020
ECG Cables and Leadwires
Xinkang Medical Instrument Co. , Ltd.
Cardiovascular
133d
Cleared
Jul 02, 2020
AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector
Atrility Medical, LLC
Cardiovascular
108d
Cleared
Jun 22, 2020
Patient Monitoring Cable (SpO2 Extension Cable)
Shenzhen Coreray Technology, Ltd.
Anesthesiology
293d
Cleared
May 12, 2020
Disposable ECG Cable
Shenzhen Changke Connect Electronics Co., Ltd.
Cardiovascular
127d
Cleared
Jan 17, 2020
SureLead Cable System
Authentic Medical
Cardiovascular
632d
Cleared
Nov 27, 2019
ECG Cable
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 5 submissions in the last 24 months.
FDA 510(k) Review Time - DSA Product Code
Recent submissions under DSA have taken an average of 104 days to reach a decision - down from 124 days historically, suggesting improved FDA processing for this classification.
DSA devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →