Atlas FDA

DRX

329 FDA 510(k) clearances · Product code

86 daysmedian time to decision
276 days90th percentile
329clearances measured

FDA profile

Official device name
Electrode, Electrocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2360
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2021: 55 · 2022: 61 · 2023: 113 · 2024: 61 · 2025: 250 · 2026: 194
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Physiotrace (K171244)Nimbleheart, Inc.2017-08-23
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE (K140096)Hmicro, Inc.2014-07-24
BIOMODULE 3-M1 (K123658)Zephyr Technology Corporation2013-04-24
CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES (K101576)Team Innovations, Inc.2010-07-22
IP-SET (K101685)Integral Process Sas2010-07-01
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X (K100129)Ambu A/S2010-06-11
INTCO TAB ELECTRODE (K093327)Shanghai Intco Electrode Manufacturing Co., Ltd.2010-05-10
12 LEAD GLOVE (K100315)I Needmd, Inc.2010-04-23
NEONATAL ECG ELECTRODE, M203KEN (K092744)R & D Medical Products, Inc.2009-12-10
DISPOSAL ECG ELECTRODES, MODEL EASYRODE (K092389)Suzuken Co., Ltd.2009-10-13
QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH (K090496)Cardiac Lead Technologies, Inc.2009-09-01
SKINTACT AND VARIOUS OTHER TRADENAMES (K092291)Leonhard Lang GmbH2009-08-21
CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES (K091856)Conmed Corporation2009-08-07
TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE (K090180)Vermed, Inc.2009-06-17
PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 (K083677)Commwell , Ltd.2009-03-10
TELECTRODE WET GEL ECG ELECTRODE (K083148)Bio Protech, Inc.2008-11-07
AUDICOR SENSOR, MODELS: 2.0, 3.0 (K080602)Inovise Medical, Inc.2008-09-25
SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE (K080106)Leonhard Lang GmbH2008-02-01
SKINTACT AND VARIOUS OTHER TRADENAMES (K073104)Leonhard Lang GmbH2007-11-16
TEXTRONICS ECG ELECTRODE (K071576)Textronics, Inc.2007-11-02
CARDIOBELT ELECTRODE BELT (K063044)Monebo Technologies, Inc.2007-03-23
ORI F6T DRY ECG MONITORING ELECTRODE (K062760)Orbital Research, Inc.2006-12-11
AMBU WHITE SENSOR CFM, CFL (K052944)Ambu A/S2006-10-25
AMBU BLUE SENSOR NEO AND NEO X (K053550)Ambu A/S2006-10-25
MACTRODE 3 (K060661)Ge Medical Systems Information Technologies2006-04-07
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 (K053011)Bio Protech, Inc.2005-12-14
ACCU-LEAD (K050443)Kentec Medical, Inc.2005-09-02
ELECTRODE (K050248)Electramold2005-05-25
ACCUHEART ELECTRODE BELT (K043361)Advanced Bioelectric Corporation2005-03-22
12-LEAD GLOVE (K033559)Ineedmd2004-12-22
AMBU DISPOSABLE ECG ELECTRODE (K041734)Ambu, Inc.2004-09-22
DISPOSABLE MONITORING ELECTRODES (K041954)Shanghai Intco Electrode Manufacturing Co., Ltd.2004-09-15
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S (K041026)Ambu, Inc.2004-06-28
PROTAB ECG TABB ELECTRODE (K040784)Bio Protech, Inc.2004-04-07
SKINTACT ECG ELECTRODE (K040249)Leonhard Lang GmbH2004-02-24
AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) (K030316)Inovise Medical, Inc.2003-08-07
BODY SIGNAL ECG ELECTRODE (K031174)Wandy Rubber Industrial Co., Ltd.2003-07-10
VERMED A10021 RESTING EKG TAB ELECTRODE (K030073)Vermont Medical, Inc.2003-03-28
SKINTACT ECG TAB ELECTRODE (K030509)Leonhard Lang GmbH2003-03-04
SKINTACT (K024264)Leonhard Lang Co.2003-01-16
SKINTACT (K023920)Leonhard Lang GmbH2003-01-16
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL (K024247)Leonhard Lang GmbH2003-01-16
NIKOMED TRACE 1 ECG ELECTRODES (K022909)Nikomed U.S.A., Inc.2003-01-09
SKINTACT ECG ELECTRODE (K023503)Leonhard Lang GmbH2002-11-14
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE (K020003)Bio Protech, Inc.2002-11-07
BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA (K020382)Medicotest A/S2002-06-28
NEOLEAD (K011564)Neotech Products, Inc.2002-01-03
SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 (K003804)Niko Medical Products2001-08-30
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 (K002230)Cambridge Heart, Inc.2000-08-18
V QUICK PATCH (K993934)Vq Corp.2000-08-15
3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE (K000690)Minnesota Mining and Mfg. Co.2000-05-17
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 (K000206)Axelgaard Mfg. Co., Ltd.2000-04-13
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 (K990113)Maersk Medical A/S1999-12-06
DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 (K990115)Maersk Medical A/S1999-12-06
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 (K990111)Maersk Medical A/S1999-12-06
DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 (K990110)Maersk Medical A/S1999-12-06
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 (K990112)Maersk Medical A/S1999-12-06
ECG ELECTRODE (VARIOUS) (K991105)Conmedcorp1999-11-26
SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES (K982521)Leonhard Lang Co.1999-10-26
BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES (K983689)Medicotest A/S1999-01-15
MEDI-TRACE 4103 NEONATAL ELECTRODE (K981964)Graphic Controls Corp.1998-11-13
ECG ELECTRODES APRON (K982470)Tapuz Medical Technology , Ltd.1998-10-14
3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 (K974445)3M Healthcare1998-07-26
PALJET-B (K973663)Golden Gate Bio-Device1998-02-10
ELECTRODE, ELECTROCARDIOGRAPH (K973727)Don Tay Industries1997-12-19
NICAS(TM) ELECTRODE (K972001)Ni Medical1997-07-08
3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES (K971444)3M Medical Products Group1997-06-11
STEALTHSHIELD (K970755)Vital Connections, Inc.1997-04-15
3M RED DOT 2560 & 2570 MONITORING ELECTRODES (K970796)3M Healthcare1997-04-09
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM (K963787)Conmedcorp1997-03-11
NOAH MONITORING ELECTRODE SYSTEM (K970125)Contour Medical Technology, Inc.1997-03-04
VERSATEC 310 ELECTRODE (K963975)Versatec, Inc.1997-01-07
CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES (K963159)Cmc Sense-It, Inc.1996-12-11
MEDICOTEST ECG ELECTRODES (K961643)Medicotest, Inc.1996-12-09
TRACE RITE SOLID GEL ECG ELECTRODES (K964213)Bio-Detek, Inc.1996-11-25
MEDI-TRACE 5700 RESTING ECG ELECTRODE (K963151)Graphic Controls Corp.1996-11-19
MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE (K963038)Graphic Controls Corp.1996-11-15
MEDI-TRACE 200, MEDI-TRACE 200-30 (K960968)Graphic Controls Corp.1996-10-28
CAMBRIDGE HEART HI-RES ECG ELECTRODE (K962115)Cambridge Heart, Inc.1996-08-29
BODYTRODE (K961288)Marquette Electronics, Inc.1996-08-08
SENTRY RADIOTRANSLUCENT ECG ELECTRODES (K962122)Sentry Medical Products, Inc.1996-07-24
G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE (K955815)Cmc Sense-It, Inc.1996-07-23
PACEART WRIST ELECTRODES (K960721)Paceart, Inc.1996-07-18
QUICKELS QS 200 SYSTEM (K954772)Ferguson Medical1996-07-11
QUICKELS QS 100 SYSTEM (K954773)Ferguson Medical1996-07-11
DISPOSABLE ECG ELECTRODE (K953649)Kendall-Ltp1996-06-21
MEDI-TRACE RADIOLUCENT (K961395)Graphic Controls Corp.1996-06-07
UNILECT, MONITAB AND BIOTRACE-HR (K944497)Msb , Ltd.1996-05-17
SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODE (K955800)Cmc Sense-It, Inc.1996-05-17
BIOTRACE-N, NS, 410 AND RT (K944496)Msb , Ltd.1996-05-16
CONMED ECG/EKG ELECTRODES (K954389)Conmedcorp1996-05-16
CONMED EKG STRIPPER (K960264)Conmedcorp1996-04-09
CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE (K954388)Conmedcorp1996-02-06
DISPOSABLE ECG MONITORING ELECTRODE (K950473)Nikomed U.S.A., Inc.1995-12-12
DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540 (K950475)Nikomed U.S.A., Inc.1995-11-14
DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM (K950472)Nikomed U.S.A., Inc.1995-11-14
DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM (K950480)Nikomed U.S.A., Inc.1995-11-06
DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM (K950471)Nikomed U.S.A., Inc.1995-11-06
DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM (K950477)Nikomed U.S.A., Inc.1995-11-06
DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM (K950478)Nikomed U.S.A., Inc.1995-11-06
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