Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DRX — Predicate Candidate Screening
329 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
276 days90th percentile
329clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171244 | Physiotrace | Nimbleheart, Inc. | 2017-08-23 | 117 | 0 |
| K140096 | HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE | Hmicro, Inc. | 2014-07-24 | 191 | 0 |
| K123658 | BIOMODULE 3-M1 | Zephyr Technology Corporation | 2013-04-24 | 147 | 0 |
| K101576 | CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING | Team Innovations, Inc. | 2010-07-22 | 45 | 0 |
| K101685 | IP-SET | Integral Process Sas | 2010-07-01 | 15 | 0 |
| K100129 | AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X | Ambu A/S | 2010-06-11 | 143 | 0 |
| K093327 | INTCO TAB ELECTRODE | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2010-05-10 | 196 | 0 |
| K100315 | 12 LEAD GLOVE | I Needmd, Inc. | 2010-04-23 | 78 | 0 |
| K092744 | NEONATAL ECG ELECTRODE, M203KEN | R & D Medical Products, Inc. | 2009-12-10 | 93 | 0 |
| K092389 | DISPOSAL ECG ELECTRODES, MODEL EASYRODE | Suzuken Co., Ltd. | 2009-10-13 | 69 | 0 |
| K090496 | QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH | Cardiac Lead Technologies, Inc. | 2009-09-01 | 188 | 0 |
| K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES | Leonhard Lang GmbH | 2009-08-21 | 23 | 0 |
| K091856 | CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 25 | Conmed Corporation | 2009-08-07 | 45 | 0 |
| K090180 | TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE | Vermed, Inc. | 2009-06-17 | 145 | 0 |
| K083677 | PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 | Commwell , Ltd. | 2009-03-10 | 89 | 0 |
| K083148 | TELECTRODE WET GEL ECG ELECTRODE | Bio Protech, Inc. | 2008-11-07 | 14 | 0 |
| K080602 | AUDICOR SENSOR, MODELS: 2.0, 3.0 | Inovise Medical, Inc. | 2008-09-25 | 206 | 0 |
| K080106 | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE | Leonhard Lang GmbH | 2008-02-01 | 17 | 0 |
| K073104 | SKINTACT AND VARIOUS OTHER TRADENAMES | Leonhard Lang GmbH | 2007-11-16 | 14 | 0 |
| K071576 | TEXTRONICS ECG ELECTRODE | Textronics, Inc. | 2007-11-02 | 147 | 0 |
| K063044 | CARDIOBELT ELECTRODE BELT | Monebo Technologies, Inc. | 2007-03-23 | 170 | 0 |
| K062760 | ORI F6T DRY ECG MONITORING ELECTRODE | Orbital Research, Inc. | 2006-12-11 | 87 | 0 |
| K052944 | AMBU WHITE SENSOR CFM, CFL | Ambu A/S | 2006-10-25 | 370 | 0 |
| K053550 | AMBU BLUE SENSOR NEO AND NEO X | Ambu A/S | 2006-10-25 | 309 | 0 |
| K060661 | MACTRODE 3 | Ge Medical Systems Information Technologies | 2006-04-07 | 25 | 0 |
| K053011 | PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 | Bio Protech, Inc. | 2005-12-14 | 49 | 0 |
| K050443 | ACCU-LEAD | Kentec Medical, Inc. | 2005-09-02 | 192 | 0 |
| K050248 | ELECTRODE | Electramold | 2005-05-25 | 111 | 0 |
| K043361 | ACCUHEART ELECTRODE BELT | Advanced Bioelectric Corporation | 2005-03-22 | 105 | 0 |
| K033559 | 12-LEAD GLOVE | Ineedmd | 2004-12-22 | 406 | 0 |
| K041734 | AMBU DISPOSABLE ECG ELECTRODE | Ambu, Inc. | 2004-09-22 | 89 | 0 |
| K041954 | DISPOSABLE MONITORING ELECTRODES | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2004-09-15 | 57 | 0 |
| K041026 | AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S | Ambu, Inc. | 2004-06-28 | 68 | 0 |
| K040784 | PROTAB ECG TABB ELECTRODE | Bio Protech, Inc. | 2004-04-07 | 9 | 0 |
| K040249 | SKINTACT ECG ELECTRODE | Leonhard Lang GmbH | 2004-02-24 | 21 | 0 |
| K030316 | AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) | Inovise Medical, Inc. | 2003-08-07 | 189 | 0 |
| K031174 | BODY SIGNAL ECG ELECTRODE | Wandy Rubber Industrial Co., Ltd. | 2003-07-10 | 87 | 0 |
| K030073 | VERMED A10021 RESTING EKG TAB ELECTRODE | Vermont Medical, Inc. | 2003-03-28 | 79 | 0 |
| K030509 | SKINTACT ECG TAB ELECTRODE | Leonhard Lang GmbH | 2003-03-04 | 13 | 0 |
| K024264 | SKINTACT | Leonhard Lang Co. | 2003-01-16 | 24 | 0 |
| K023920 | SKINTACT | Leonhard Lang GmbH | 2003-01-16 | 52 | 0 |
| K024247 | SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL | Leonhard Lang GmbH | 2003-01-16 | 24 | 2 |
| K022909 | NIKOMED TRACE 1 ECG ELECTRODES | Nikomed U.S.A., Inc. | 2003-01-09 | 128 | 0 |
| K023503 | SKINTACT ECG ELECTRODE | Leonhard Lang GmbH | 2002-11-14 | 27 | 0 |
| K020003 | ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE | Bio Protech, Inc. | 2002-11-07 | 309 | 0 |
| K020382 | BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA | Medicotest A/S | 2002-06-28 | 143 | 0 |
| K011564 | NEOLEAD | Neotech Products, Inc. | 2002-01-03 | 227 | 0 |
| K003804 | SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550 | Niko Medical Products | 2001-08-30 | 265 | 0 |
| K002230 | CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 | Cambridge Heart, Inc. | 2000-08-18 | 25 | 1 |
| K993934 | V QUICK PATCH | Vq Corp. | 2000-08-15 | 271 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda