Panels › Cardiovascular › Product code DSA · Class 2
Cable, Transducer And Electrode, Patient, (Including Connector)
Regulation 870.2900
2510(k)s in 12 months (105 all time)
0recalls in 12 months (12 all time)
6recalls that name a 510(k)
Top companies in DSA
| Company | 510(k)s | Recalls |
|---|---|---|
| GE Healthcare, LLC | 0 | 5 |
| Medtronic Vascular | 5 | 0 |
| Remington Medical, Inc. | 2 | 2 |
| Tronomed, Inc. | 4 | 0 |
| Arbo Medical, Inc. | 3 | 0 |
| Vyaire Medical, Inc. | 3 | 0 |
| Baylis Medical Technologies, Inc. | 2 | 0 |
| Beijing Rongrui-Century Science & Technology Co., Ltd. | 2 | 0 |
| Biosense Webster, Inc. | 1 | 1 |
| Boston Scientific | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 18, 2026 | K254114 | Baylis Connector Cable Baylis Medical Technologies, Inc., CA | DSA |
| Dec 1, 2025 | K252827 | IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (26 Drägerwerk AG & Co. KGaA, DE | DSA |
| Sep 30, 2025 | K251669 | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adap Shanghai Draeger Medical Instrument Co., Ltd., CN | DSA |
| May 2, 2025 | K242986 | SpO2 Extension Cable Beijing Rongrui-Century Science & Technology Co., Ltd., CN | DSA |
| Jan 17, 2025 | K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI Philips Medizin Systeme Böblingen GmbH, DE | DSA |
| Sep 13, 2024 | K240087 | RT Carbon ECG Leads Ivy Biomedical Systems, Inc. | DSA |
| May 7, 2024 | K240377 | LIFEPAK® ECG Cables Stryker Physio-Control | DSA |
| Apr 30, 2024 | K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equ Physio-Control, Inc. | DSA |
| Nov 22, 2023 | K222712 | Fogg System Patient Monitoring Cables Fogg System Company, Inc. | DSA |
| May 30, 2023 | K230571 | RFP-100A Connector Cable (Single Use) Baylis Medical Technologies, Inc., CA | DSA |
| Apr 2, 2023 | K222370 | SpO2 Extension Cable Beijing Rongrui-Century Science & Technology Co., Ltd., CN | DSA |
| Jun 28, 2022 | K220447 | Med-link Disposable ECG Cable and Leadwires Shenzhen Med-Link Electronics Tech Co., Ltd., CN | DSA |
| Jan 27, 2022 | K211941 | 9Line Energetic Designs, Inc. | DSA |
| Aug 16, 2021 | K211294 | Multi-Link X2 ECG Cable and Leadwire System Vyaire Medical, Inc. | DSA |
| Jul 12, 2021 | K203556 | Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables Medtronic, Inc. | DSA |
| Jun 3, 2021 | K200722 | PCA-C1 series Patient Cable QT Medical, Inc. | DSA |
| Feb 5, 2021 | K203635 | Patient Monitoring Cables Jkh USA, LLC | DSA |
| Oct 9, 2020 | K200510 | Multi-LinkTM X2 ECG Adapter and Leadwires Vyaire Medical, Inc. | DSA |
| Oct 1, 2020 | K201359 | ECG Cables and Leadwires Xinkang Medical Instrument Co. , Ltd., CN | DSA |
| Jul 2, 2020 | K200674 | AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector Atrility Medical, LLC | DSA |
| Jun 22, 2020 | K192404 | Patient Monitoring Cable (SpO2 Extension Cable) Shenzhen Coreray Technology, Ltd., CN | DSA |
| May 12, 2020 | K200026 | Disposable ECG Cable Shenzhen Changke Connect Electronics Co., Ltd., CN | DSA |
| Jan 17, 2020 | K181089 | SureLead Cable System Authentic Medical | DSA |
| Nov 27, 2019 | K191428 | ECG Cable Shenzhen Changke Connect Electronics Co., Ltd., CN | DSA |
| Sep 13, 2019 | K191273 | Multi-Link X2 ECG and SpO2 Adapter Vyaire Medical, Inc. | DSA |
| Feb 11, 2019 | K190078 | IntraSight Volcano Corporation | DSA |
| Jan 30, 2019 | K182327 | Patient Cables and Leadwires , Disposable ECG Leadwires Orantech, Inc., CN | DSA |
| Nov 7, 2018 | K182220 | Curbell branded Patient Monitoring Cables Curbell Medical Products, Inc. | DSA |
| Sep 20, 2018 | K181726 | Medline Patient Cables and Lead Wires Medline Industries, Inc. | DSA |
| Feb 28, 2018 | K172797 | ECG Cable/Leadwires Shenzhen Coreray Technology, Ltd., CN | DSA |
| Nov 3, 2017 | K172591 | Fixed Patient Leads ECG Cable (Model 3153) Boston Scientific Corporation | DSA |
| Aug 16, 2017 | K162768 | ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwi Integral Process Sas, FR | DSA |
| Jun 22, 2017 | K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System Carefusion 303, Inc. | DSA |
| Apr 24, 2017 | K170536 | ECG Disposable Lead Wire APK Technology Co., Ltd., CN | DSA |
| Jan 18, 2017 | K162432 | Multi-Link X2 ECG Cable and Lead Wire System Carefusion 2200, Inc. | DSA |
| Oct 24, 2016 | K153188 | Caremed patient cable and leadwires Shenzhen Caremed Medical Technology Co., Ltd., CN | DSA |
| Apr 5, 2016 | K152947 | Disposable Temporary Pacing Cable Tiger Medical Products, CN | DSA |
| Nov 4, 2014 | K142489 | Unimed Disposable ECG lead wires Unimed Medical Supplies, Inc., CN | DSA |
| Dec 16, 2013 | K132253 | REMOVABLE PATIENT LEADS ECG CABLE Boston Scientific | DSA |
| Jan 19, 2012 | K120010 | CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE) Shenzhen Med-Link Electronics Tech Co., Ltd., CN | DSA |
| Feb 15, 2011 | K110287 | PHILIPS ECG LEADWIRE SET Philips Medical Systems | DSA |
| Sep 10, 2010 | K102430 | TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET Tyco Electronics Corporation | DSA |
| Aug 11, 2010 | K101660 | ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8 Kepler Medtec | DSA |
| Apr 2, 2010 | K093858 | PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A St. Jude Medical, Cardiac Rhythm Management Divisi | DSA |
| Jan 15, 2010 | K093657 | ADAGIO RETRACTING ECG LEAD WIRES Acist Medical Systems, Inc. | DSA |
| Nov 19, 2008 | K082851 | MULTLINK CABLE AND LEADWIRE SYSTEM Ge Medical Systems Information Technologies | DSA |
| Oct 10, 2008 | K082959 | PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS Unimed Medical Supplies, Inc., CN | DSA |
| Aug 27, 2008 | K081762 | CURBELL PATIENT MONITORING CABLES Curbell Electronics, Inc. | DSA |
| Jun 20, 2008 | K080112 | PATIENT CABLE Med-Dyne | DSA |
| May 5, 2008 | K080605 | SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL Curbell Electronics, Inc. | DSA |
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