Atlas FDA

DSA

105 FDA 510(k) clearances · Product code

85 daysmedian time to decision
264 days90th percentile
105clearances measured

FDA profile

Official device name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2900
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2020: 31 · 2022: 49 · 2023: 29 · 2024: 40 · 2025: 68 · 2026: 77
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Baylis Connector Cable (K254114)Baylis Medical Technologies, Inc.2026-01-18
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) (K252827)Drägerwerk AG & Co. KGaA2025-12-01
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 (K251669)Shanghai Draeger Medical Instrument Co., Ltd.2025-09-30
SpO2 Extension Cable (K242986)Beijing Rongrui-Century Science & Technology Co., Ltd.2025-05-02
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 (K243545)Philips Medizin Systeme Böblingen GmbH2025-01-17
RT Carbon ECG Leads (K240087)Ivy Biomedical Systems, Inc.2024-09-13
LIFEPAK® ECG Cables (K240377)Stryker Physio-Control2024-05-07
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) (K240156)Physio-Control, Inc.2024-04-30
Fogg System Patient Monitoring Cables (K222712)Fogg System Company, Inc.2023-11-22
RFP-100A Connector Cable (Single Use) (K230571)Baylis Medical Technologies, Inc.2023-05-30
SpO2 Extension Cable (K222370)Beijing Rongrui-Century Science & Technology Co., Ltd.2023-04-02
Med-link Disposable ECG Cable and Leadwires (K220447)Shenzhen Med-Link Electronics Tech Co., Ltd.2022-06-28
9Line (K211941)Energetic Designs, Inc.2022-01-27
Multi-Link X2 ECG Cable and Leadwire System (K211294)Vyaire Medical, Inc.2021-08-16
Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables (K203556)Medtronic, Inc.2021-07-12
PCA-C1 series Patient Cable (K200722)QT Medical, Inc.2021-06-03
Patient Monitoring Cables (K203635)Jkh USA, LLC2021-02-05
Multi-LinkTM X2 ECG Adapter and Leadwires (K200510)Vyaire Medical, Inc.2020-10-09
ECG Cables and Leadwires (K201359)Xinkang Medical Instrument Co. , Ltd.2020-10-01
AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector (K200674)Atrility Medical, LLC2020-07-02
Patient Monitoring Cable (SpO2 Extension Cable) (K192404)Shenzhen Coreray Technology, Ltd.2020-06-22
Disposable ECG Cable (K200026)Shenzhen Changke Connect Electronics Co., Ltd.2020-05-12
SureLead Cable System (K181089)Authentic Medical2020-01-17
ECG Cable (K191428)Shenzhen Changke Connect Electronics Co., Ltd.2019-11-27
Multi-Link X2 ECG and SpO2 Adapter (K191273)Vyaire Medical, Inc.2019-09-13
IntraSight (K190078)Volcano Corporation2019-02-11
Patient Cables and Leadwires , Disposable ECG Leadwires (K182327)Orantech, Inc.2019-01-30
Curbell branded Patient Monitoring Cables (K182220)Curbell Medical Products, Inc.2018-11-07
Medline Patient Cables and Lead Wires (K181726)Medline Industries, Inc.2018-09-20
ECG Cable/Leadwires (K172797)Shenzhen Coreray Technology, Ltd.2018-02-28
Fixed Patient Leads ECG Cable (Model 3153) (K172591)Boston Scientific Corporation2017-11-03
ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables (K162768)Integral Process Sas2017-08-16
Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System (K163316)Carefusion 303, Inc.2017-06-22
ECG Disposable Lead Wire (K170536)APK Technology Co., Ltd.2017-04-24
Multi-Link X2 ECG Cable and Lead Wire System (K162432)Carefusion 2200, Inc.2017-01-18
Caremed patient cable and leadwires (K153188)Shenzhen Caremed Medical Technology Co., Ltd.2016-10-24
Disposable Temporary Pacing Cable (K152947)Tiger Medical Products2016-04-05
Unimed Disposable ECG lead wires (K142489)Unimed Medical Supplies, Inc.2014-11-04
REMOVABLE PATIENT LEADS ECG CABLE (K132253)Boston Scientific2013-12-16
CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE) (K120010)Shenzhen Med-Link Electronics Tech Co., Ltd.2012-01-19
PHILIPS ECG LEADWIRE SET (K110287)Philips Medical Systems2011-02-15
TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET (K102430)Tyco Electronics Corporation2010-09-10
ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8 (K101660)Kepler Medtec2010-08-11
PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A (K093858)St. Jude Medical, Cardiac Rhythm Management Divisi2010-04-02
ADAGIO RETRACTING ECG LEAD WIRES (K093657)Acist Medical Systems, Inc.2010-01-15
MULTLINK CABLE AND LEADWIRE SYSTEM (K082851)Ge Medical Systems Information Technologies2008-11-19
PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS (K082959)Unimed Medical Supplies, Inc.2008-10-10
CURBELL PATIENT MONITORING CABLES (K081762)Curbell Electronics, Inc.2008-08-27
PATIENT CABLE (K080112)Med-Dyne2008-06-20
SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL (K080605)Curbell Electronics, Inc.2008-05-05
FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 (K080621)European Custom Manufacturing BV2008-04-29
LIFESYNC ADAPTER, MODEL LS-302 (K071751)Lifesync Corporation2007-08-27
ECG CABLES, TRUNK AND PATIENT LEAD WIRES (K070232)American I.V. Products, Inc.2007-03-27
V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC (K062577)Tz Medical, Inc.2006-12-15
COMPATIBILITY ECG TRUNK CABLES (K043572)Datex-Ohmeda2005-02-22
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES (K030005)Vanguard Medical Concepts, Inc.2003-03-18
BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 (K023334)Baylis Medical Co., Inc.2002-12-31
DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 (K022075)Cp Medical2002-09-19
REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES (K013598)C.R. Bard, Inc.2002-01-11
DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 (K012392)Pace Medical2001-09-04
BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000 (K010809)Rf Industries, Ltd.2001-05-23
MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS (K002781)Medical Cables, Inc.2000-11-29
BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES (K001390)Biosense Webster, Inc.2000-07-21
PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES (K992524)Advantage Medical Electronics, Inc.2000-03-01
EWC: ECG II CABLE LEADWIRE SYSTEM (K984263)Ewc1999-02-02
EWC: ECG CABLE AND LEADWIRE SYSTEMS (K982817)Ewc1998-09-23
AFFINITY MEDICAL PATIENT CABLE SYSTEM (K980806)Affinity Medical Technologies, LLC1998-03-25
MULTI-LINK CABLE AND LEAD WIRE SYSTEMS (K980582)Marquette Medical Systems, Inc.1998-03-16
SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) (K971968)Remington Medical, Inc.1997-07-23
3M RED DOT ECG LEAD WIRES A (K954900)Minnesota Mining and Mfg. Co.1996-07-15
MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES (K960446)Medtronic Vascular1996-05-22
TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM (K952659)Tronomed, Inc.1996-01-11
ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM (K940323)Arbo Medical, Inc.1995-04-12
ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & LEAD SYSTEM (K940302)Arbo Medical, Inc.1994-11-30
ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE (K940322)Arbo Medical, Inc.1994-11-28
VARIOUSPATIENT MONITORING CABLE (K942321)Merit Cables Incorporated1994-11-04
CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES (K945034)Conmedcorp1994-10-27
DISPOSABLE SURGICAL CABLE (K941839)Conmed Andover Medical, Inc.1994-07-27
PROCATH PACING THRESHOLD CABLE (K941058)Professional Catheter Corp.1994-07-11
CONMED ECG PATIENT CABLES AND LEADWIRES (K933649)Conmedcorp1994-02-18
LEADWIRE (K933603)Sentry Medical Products, Inc.1994-01-18
PATIENT CABLE (K932704)Sentry Medical Products, Inc.1993-12-27
DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101 (K922009)Remington Medical, Inc.1993-02-25
MODEL 4280 SURGICAL EXTENSION CABLE (K922899)Pace Medical1992-12-23
DISPOSABLE PATIENT CABLE (K910645)Diag Corp.1991-05-07
RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE (K901780)Medtronic Vascular1990-10-09
MEDTRONIC MODEL 5455S DISPOSABLE SURGICAL CABLE (K894981)Medtronic Vascular1989-09-20
ASTRO TRACE (MODEL AT-02) (K885137)The LE Blanc Corp.1989-03-15
ASTRO TRACE (MODEL AT-01) (K884592)The LE Blanc Corp.1989-03-02
MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR (K885101)Medtronic Vascular1989-01-12
MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE (K882174)Medtronic Andover Medical, Inc.1988-07-22
MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR (K880323)Medtronic Vascular1988-03-22
ELECTRODE CABLE (K880320)Vital Connections, Inc.1988-03-22
BSK-1033 TELEMETRY MONITORING CABLE (K873492)Desco Industries, Inc.1987-10-09
ADAPTAID TEMP. PACING EXT. LEAD #366-02 (K820268)Intermedics, Inc.1982-03-26
CORROSION PROOF DUAL PURPOSE ECG WIRES (K802237)Custom Cardio Components1980-10-03
CORROSION PROOF SNAP ECG CONNECT WIRES (K802236)Custom Cardio Components1980-10-03
3M R.F. CURRENT SUPPRESSOR (K801041)3M Company1980-05-23
R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122 (K800931)R2 Corp.1980-05-23
ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120 (K800932)R2 Corp.1980-05-23
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