Product code DRX— Cardiovascular
ECG ELECTRODE
- Classification name
- Electrode, Electrocardiograph
- Device class
- Class 2
- Regulation
- 21 CFR 870.2360
- Advisory panel
- Cardiovascular
- Total cleared
- 329
- First cleared
- Most recent
Market context for product code DRX
FDA has cleared devices under product code DRX between 1976 and 2017, filed by 146 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2017
- 2014
- 2013
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
Top applicants under product code DRX
Adverse events under product code DRX
product code DRX- Death
- 6
- Injury
- 476
- Other
- 2
- Total
- 484
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DRX
1–100 of 329- K171244 — Physiotrace
- K140096 — HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
- K123658 — BIOMODULE 3-M1
- K101576 — CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES
- K101685 — IP-SET
- K100129 — AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
- K093327 — INTCO TAB ELECTRODE
- K100315 — 12 LEAD GLOVE
- K092744 — NEONATAL ECG ELECTRODE, M203KEN
- K092389 — DISPOSAL ECG ELECTRODES, MODEL EASYRODE
- K090496 — QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH
- K092291 — SKINTACT AND VARIOUS OTHER TRADENAMES
- K091856 — CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES
- K090180 — TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE
- K083677 — PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1
- K083148 — TELECTRODE WET GEL ECG ELECTRODE
- K080602 — AUDICOR SENSOR, MODELS: 2.0, 3.0
- K080106 — SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE
- K073104 — SKINTACT AND VARIOUS OTHER TRADENAMES
- K071576 — TEXTRONICS ECG ELECTRODE
- K063044 — CARDIOBELT ELECTRODE BELT
- K062760 — ORI F6T DRY ECG MONITORING ELECTRODE
- K052944 — AMBU WHITE SENSOR CFM, CFL
- K053550 — AMBU BLUE SENSOR NEO AND NEO X
- K060661 — MACTRODE 3
- K053011 — PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20
- K050443 — ACCU-LEAD
- K050248 — ELECTRODE
- K043361 — ACCUHEART ELECTRODE BELT
- K033559 — 12-LEAD GLOVE
- K041734 — AMBU DISPOSABLE ECG ELECTRODE
- K041954 — DISPOSABLE MONITORING ELECTRODES
- K041026 — AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
- K040784 — PROTAB ECG TABB ELECTRODE
- K040249 — SKINTACT ECG ELECTRODE
- K030316 — AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)
- K031174 — BODY SIGNAL ECG ELECTRODE
- K030073 — VERMED A10021 RESTING EKG TAB ELECTRODE
- K030509 — SKINTACT ECG TAB ELECTRODE
- K023920 — SKINTACT
- K024247 — SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
- K024264 — SKINTACT
- K022909 — NIKOMED TRACE 1 ECG ELECTRODES
- K023503 — SKINTACT ECG ELECTRODE
- K020003 — ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
- K020382 — BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
- K011564 — NEOLEAD
- K003804 — SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
- K002230 — CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
- K993934 — V QUICK PATCH
- K000690 — 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE
- K000206 — PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
- K990110 — DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
- K990111 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
- K990112 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
- K990113 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560
- K990115 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440
- K991105 — ECG ELECTRODE (VARIOUS)
- K982521 — SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES
- K983689 — BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES
- K981964 — MEDI-TRACE 4103 NEONATAL ELECTRODE
- K982470 — ECG ELECTRODES APRON
- K974445 — 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360
- K973663 — PALJET-B
- K973727 — ELECTRODE, ELECTROCARDIOGRAPH
- K972001 — NICAS(TM) ELECTRODE
- K971444 — 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES
- K970755 — STEALTHSHIELD
- K970796 — 3M RED DOT 2560 & 2570 MONITORING ELECTRODES
- K963787 — EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM
- K970125 — NOAH MONITORING ELECTRODE SYSTEM
- K963975 — VERSATEC 310 ELECTRODE
- K963159 — CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES
- K961643 — MEDICOTEST ECG ELECTRODES
- K964213 — TRACE RITE SOLID GEL ECG ELECTRODES
- K963151 — MEDI-TRACE 5700 RESTING ECG ELECTRODE
- K963038 — MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE
- K960968 — MEDI-TRACE 200, MEDI-TRACE 200-30
- K962115 — CAMBRIDGE HEART HI-RES ECG ELECTRODE
- K961288 — BODYTRODE
- K962122 — SENTRY RADIOTRANSLUCENT ECG ELECTRODES
- K955815 — G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE
- K960721 — PACEART WRIST ELECTRODES
- K954772 — QUICKELS QS 200 SYSTEM
- K954773 — QUICKELS QS 100 SYSTEM
- K953649 — DISPOSABLE ECG ELECTRODE
- K961395 — MEDI-TRACE RADIOLUCENT
- K944497 — UNILECT, MONITAB AND BIOTRACE-HR
- K955800 — SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODE
- K944496 — BIOTRACE-N, NS, 410 AND RT
- K954389 — CONMED ECG/EKG ELECTRODES
- K960264 — CONMED EKG STRIPPER
- K954388 — CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE
- K950473 — DISPOSABLE ECG MONITORING ELECTRODE
- K950472 — DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM
- K950475 — DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540
- K950470 — DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM
- K950471 — DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM
- K950474 — DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM
- K950477 — DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM
Data sourced from openFDA. This site is unofficial and independent of the FDA.