Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MKJ — Predicate Candidate Screening
228 FDA 510(k) clearances under this product code; the 50 most recent screened below.
132 daysmedian FDA review time
322 days90th percentile
228clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143714 | Powerheart G5 AED | Cardiac Science Corporation | 2015-05-04 | 126 | 0 |
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-pa | Bio-Detek, Inc. | 2015-05-02 | 93 | 0 |
| K150055 | OneStep Pediatric CPR Multi-Function Electrode | Bio-Detek, Inc. | 2015-05-02 | 110 | 0 |
| K142709 | samaritan PAD 450P | Heartsine Technologies, Inc. | 2015-03-27 | 186 | 0 |
| K133659 | HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DI | Philips Medical Systems | 2015-01-23 | 422 | 0 |
| K133239 | ZOLL E SERIES | Zoll Medical Corporation, World Wide Headquarters | 2015-01-16 | 452 | 0 |
| K142430 | LIFEPAK 15 monitor/defibrillator | Physio-Control, Inc. | 2014-12-19 | 112 | 4 |
| K141795 | BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 | R & D Batteries, Inc. | 2014-12-08 | 158 | 0 |
| K142915 | ZOLL X Series | ZOLL Medical Corporation | 2014-12-03 | 57 | 0 |
| K142803 | Skintact, various other tradenames | Leonhard Lang GmbH | 2014-12-02 | 64 | 2 |
| K141231 | ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY | Zeller Power Products (Battery Beast, LLC) | 2014-11-25 | 196 | 0 |
| K141774 | ZOLL X SERIES | ZOLL Medical Corporation | 2014-11-19 | 140 | 0 |
| K133441 | ONESTEP CPR II MULTI-FUNCTION ELECTRODE | Bio-Detek, Inc. | 2014-10-10 | 332 | 0 |
| K133484 | ZOLL X SERIES | Zoll Medical Corp | 2014-08-01 | 261 | 0 |
| K133269 | ZOLL X SERIES | Zoll Medical Corporation, World Wide Headquarters | 2014-05-22 | 210 | 0 |
| K131525 | SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | Defibtech, LLC | 2014-04-24 | 331 | 0 |
| K122758 | POWERHEART G5 AED | Cardiac Science Corporation | 2014-02-12 | 520 | 0 |
| K131550 | HEART SYNC | Heart Sync, Inc. | 2013-12-06 | 191 | 0 |
| K130684 | PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR | Philips Medical Systems | 2013-10-18 | 219 | 1 |
| K131494 | HEART SYNC | Heart Sync, Inc. | 2013-09-16 | 116 | 0 |
| K130454 | LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/ | Physio-Control, Inc. | 2013-08-21 | 180 | 1 |
| K123881 | HEARTSINE SAMARITAN PAD 350P | Heartsine Technologies, Inc. | 2013-07-11 | 206 | 1 |
| K130153 | HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST | Philips Medical Systems | 2013-03-12 | 49 | 0 |
| K113787 | DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORI | Defibtech, LLC | 2013-01-04 | 379 | 0 |
| K121853 | DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCES | Defibtech, LLC | 2012-12-13 | 171 | 0 |
| K122839 | ZOLL SUREPOWER SINGLE BAY CHARGER | ZOLL Medical Corporation | 2012-12-13 | 87 | 0 |
| K120350 | EXTENDED LIFE BATTERY | Aed Battery Exchange, LLC | 2012-11-01 | 269 | 0 |
| K120406 | ZOLL FULLY AUTOMATIC AED PLUS | Zoll Medical Corporation, World Wide Headquarters | 2012-10-26 | 260 | 0 |
| K122600 | LIFEPAK 1000 DEFIBRILLATOR | Physio-Control, Inc. | 2012-10-11 | 45 | 1 |
| K120907 | ZOLL R SERIES | Zoll Medical Corporation, World Wide Headquarters | 2012-09-25 | 183 | 0 |
| K120536 | HEART SYNC PEDIATRIC PHYSIO AED PAD | Heart Sync, Inc. | 2012-08-06 | 166 | 0 |
| K112761 | ZOLL PROPAQ MD | Zoll Medical Corporation, World Wide Headquarters | 2012-04-25 | 216 | 1 |
| K112432 | ZOLL X SERIES | Zoll Medical Corporation, World Wide Headquarters | 2012-03-21 | 211 | 2 |
| K110825 | PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, | Philips Medical Systems | 2012-02-16 | 330 | 6 |
| K111693 | PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR | Philips Medical Systems | 2011-10-28 | 134 | 1 |
| K111594 | ZOLL E SERIES | Zoll Medical Corporation, World Wide Headquarters | 2011-08-17 | 71 | 0 |
| K102496 | POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATI | Cardiac Science Corporation | 2011-06-09 | 282 | 2 |
| K110978 | ONESTEP PEDIATRIC MFE'S | ZOLL Medical Corporation | 2011-05-13 | 36 | 0 |
| K110742 | ONESTEP ADULT MULTI-FUNCTION ELECTRODE | ZOLL Medical Corporation | 2011-04-13 | 27 | 0 |
| K110526 | ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE | ZOLL Medical Corporation | 2011-03-25 | 29 | 0 |
| K103567 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | Physio-Control, Inc. | 2011-03-22 | 106 | 0 |
| K110361 | ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE | Zoll Medical Corporation, World Wide Headquarters | 2011-03-08 | 29 | 0 |
| K110154 | ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE | Zoll Medical Corporation, World Wide Headquarters | 2011-02-17 | 29 | 0 |
| K110168 | ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE | Zoll Medical Corporation, World Wide Headquarters | 2011-02-17 | 28 | 0 |
| K103186 | SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES | Leonhard Lang GmbH | 2011-02-08 | 102 | 0 |
| K102972 | LIFEPAK 12 | Physio-Control, Inc. | 2010-12-22 | 77 | 0 |
| K100565 | DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HY | Bio-Detek, Inc. | 2010-11-16 | 260 | 0 |
| K091561 | ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE | ZOLL Medical Corporation | 2010-09-23 | 483 | 0 |
| K092391 | MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED | Concord Medical Products | 2010-04-01 | 239 | 0 |
| K091265 | ZOLL E SERIES WITH CPRREADYCHARGE | Zoll Medical Corporation, World Wide Headquarters | 2009-12-23 | 237 | 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