Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LDD — Predicate Candidate Screening
166 FDA 510(k) clearances under this product code; the 50 most recent screened below.
95 daysmedian FDA review time
241 days90th percentile
166clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203231 | Switched Internal Paddles | Philips North America, LLC | 2021-01-11 | 70 | 0 |
| K200849 | Tempus LS - Manual | Remote Diagnostic Technologies, Ltd. A Philips Company | 2020-07-24 | 115 | 4 |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LI | Physio-Control, Inc. | 2019-06-03 | 264 | 1 |
| K150349 | Rapid Hair Removal Pads | Full Power Aed | 2015-07-14 | 153 | 0 |
| K140502 | ZOLL E SERIES ALS | ZOLL Medical Corporation | 2014-11-06 | 252 | 0 |
| K103651 | CARDIOMED | Cardio Medical Products, Inc. | 2011-10-04 | 294 | 0 |
| K103783 | EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: | Fiab Spa | 2011-06-16 | 171 | 0 |
| K103334 | CARDIO MED | Cardio Medical Products, Inc. | 2011-01-18 | 64 | 0 |
| K103159 | CARDIO MED MODEL A102, H104, O101, P103, AND Z100 | Cardio Medical Products, Inc. | 2011-01-11 | 77 | 1 |
| K102468 | ZOLL PROPAQ MD | Zoll Medical Corporation, World Wide Headquarters | 2010-09-30 | 31 | 0 |
| K100654 | ZOLL PROPAQ MD | Zoll Medical Corporation, World Wide Headquarters | 2010-07-29 | 143 | 0 |
| K081442 | HEART SYNC PEDIATRIC, MODEL PED-100 | Heart Sync, LLC | 2008-09-24 | 125 | 0 |
| K081574 | ZOLL R SERIES | ZOLL Medical Corporation | 2008-09-18 | 105 | 0 |
| K042302 | ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERN | Zoll Medical Corp | 2004-10-26 | 62 | 0 |
| K032691 | ZOLL AUTOCLAVABLE INTERNAL HANDLES | Zoll Medical Corp | 2003-11-13 | 72 | 0 |
| K030417 | DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED | Philips Medical Systems | 2003-05-09 | 88 | 0 |
| K011461 | ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR | Access Cardiosystems, Inc. | 2002-05-28 | 379 | 0 |
| K012274 | MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PA | Medtronic Physio-Control Corp. | 2002-02-05 | 201 | 17 |
| K993205 | BOOKER BOX, MODEL PAD 5010 | Tz Medical, Inc. | 2000-07-20 | 300 | 0 |
| K982896 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER | Alexander Mfg. Co. | 1998-10-21 | 65 | 0 |
| K971436 | NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRI | Nihon Kohden America, Inc. | 1997-10-21 | 186 | 0 |
| K971355 | NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND | Nihon Kohden America, Inc. | 1997-07-15 | 95 | 0 |
| K971194 | NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCES | Nihon Kohden America, Inc. | 1997-07-09 | 99 | 0 |
| K970481 | V2 | Survivalink Corp. | 1997-07-01 | 141 | 0 |
| K963781 | ZOLL AUTOCLAVABLE INTERNAL HANDLES | Zoll Medical Corp | 1997-05-20 | 242 | 0 |
| K964469 | 700-F SERIES STIMULATION ELECTRODES | Cardiotronics Systems, Inc. | 1996-12-11 | 34 | 4 |
| K962551 | CARDIOSERV S | Marquette Electronics, Inc. | 1996-11-19 | 144 | 0 |
| K951110 | CARDIO SERV | Hellige GmbH | 1995-09-15 | 189 | 0 |
| K952085 | DPD DEFIBRILLATOR | Medical Research Laboratories, Inc. | 1995-06-05 | 33 | 0 |
| K940842 | UNIPOWER RECHARGEABLE BATTERY PACK | Unipower Corp. | 1994-09-07 | 196 | 0 |
| K941995 | NCE REPLACEMENT BATTERIES | National Custom Ent., Inc. | 1994-07-26 | 92 | 0 |
| K935083 | PEDIATRIC DEFIB K-PADS | Katecho, Inc. | 1994-07-25 | 273 | 0 |
| K935111 | UNIPOWERR RECHARGEABLE BATTERY PACK | Unipower Corp. | 1994-03-28 | 154 | 0 |
| K922315 | VITAL-COMBO(R) | Physio-Control Corp. | 1994-03-16 | 667 | 0 |
| K934015 | RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB | Portable Power Systems, Inc. | 1994-02-17 | 184 | 0 |
| K934508 | BATTERY PACK# S1024NC | Portable Power Systems, Inc. | 1994-02-17 | 156 | 0 |
| K931266 | BATTERY PACK #1012NC | Portable Power Systems, Inc. | 1994-02-03 | 332 | 0 |
| K935674 | LIFEPAK 9 DEFIBRILLATOR/MONITOR | Physio-Control Corp. | 1993-12-16 | 8 | 0 |
| K931787 | ZOLL PD 5300 | Zoll Medical Corp | 1993-10-15 | 186 | 0 |
| K931803 | 5200 ADULT SOLID GEL MULTI-FUNCTION ELECTRODES | Zoll Medical Corp | 1993-10-08 | 179 | 0 |
| K931804 | ZOLL D 5400 ADULT SOLID GEL DEFIBRILLATION ELECTRO | Zoll Medical Corp | 1993-10-08 | 179 | 0 |
| K931805 | ZOLL PD 5200C ADULT SOLID GEL MULTI-FUNCTION ELECT | Zoll Medical Corp | 1993-10-08 | 179 | 0 |
| K921666 | CARDIAC THERAPHY SYSTEM SCP 900 | Ppg Hellige B.V. | 1993-09-23 | 534 | 0 |
| K930548 | DPD DEFIBRILLATOR | Medical Research Laboratories, Inc. | 1993-06-25 | 142 | 0 |
| K931053 | LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER | Physio-Control Corp. | 1993-05-18 | 71 | 0 |
| K921765 | PRIMEDIC DEFIBRILLATORS-N/B | Metronic Electronic GmbH | 1993-03-03 | 323 | 0 |
| K921487 | MARQUETTE SERIES 360 DEFIBRILLATOR | Marquette Electronics, Inc. | 1992-12-29 | 274 | 0 |
| K923864 | BATTERY PACK | Portable Power Systems, Inc. | 1992-10-05 | 63 | 0 |
| K923297 | MODEL #340 STEALTH-TRODE+LS | Cardiotronics, Inc. | 1992-09-18 | 74 | 0 |
| K922563 | LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR) | Raco Products Co. | 1992-07-28 | 57 | 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