Atlas FDA

LDD

166 FDA 510(k) clearances · Product code

95 daysmedian time to decision
241 days90th percentile
166clearances measured

FDA profile

Official device name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5300
Medical specialty
Cardiovascular
Flags
Life-sustaining
Adverse events (MAUDE)
2021: 22 · 2022: 80 · 2023: 264 · 2024: 160 · 2025: 74 · 2026: 30
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Switched Internal Paddles (K203231)Philips North America, LLC2021-01-11
Tempus LS - Manual (K200849)Remote Diagnostic Technologies, Ltd. A Philips Company2020-07-24
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors (K182503)Physio-Control, Inc.2019-06-03
Rapid Hair Removal Pads (K150349)Full Power Aed2015-07-14
ZOLL E SERIES ALS (K140502)ZOLL Medical Corporation2014-11-06
CARDIOMED (K103651)Cardio Medical Products, Inc.2011-10-04
EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC (K103783)Fiab Spa2011-06-16
CARDIO MED (K103334)Cardio Medical Products, Inc.2011-01-18
CARDIO MED MODEL A102, H104, O101, P103, AND Z100 (K103159)Cardio Medical Products, Inc.2011-01-11
ZOLL PROPAQ MD (K102468)Zoll Medical Corporation, World Wide Headquarters2010-09-30
ZOLL PROPAQ MD (K100654)Zoll Medical Corporation, World Wide Headquarters2010-07-29
HEART SYNC PEDIATRIC, MODEL PED-100 (K081442)Heart Sync, LLC2008-09-24
ZOLL R SERIES (K081574)ZOLL Medical Corporation2008-09-18
ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE (K042302)Zoll Medical Corp2004-10-26
ZOLL AUTOCLAVABLE INTERNAL HANDLES (K032691)Zoll Medical Corp2003-11-13
DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (K030417)Philips Medical Systems2003-05-09
ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR (K011461)Access Cardiosystems, Inc.2002-05-28
MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER (K012274)Medtronic Physio-Control Corp.2002-02-05
BOOKER BOX, MODEL PAD 5010 (K993205)Tz Medical, Inc.2000-07-20
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 (K982896)Alexander Mfg. Co.1998-10-21
NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES (K971436)Nihon Kohden America, Inc.1997-10-21
NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES (K971355)Nihon Kohden America, Inc.1997-07-15
NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES (K971194)Nihon Kohden America, Inc.1997-07-09
V2 (K970481)Survivalink Corp.1997-07-01
ZOLL AUTOCLAVABLE INTERNAL HANDLES (K963781)Zoll Medical Corp1997-05-20
700-F SERIES STIMULATION ELECTRODES (K964469)Cardiotronics Systems, Inc.1996-12-11
CARDIOSERV S (K962551)Marquette Electronics, Inc.1996-11-19
CARDIO SERV (K951110)Hellige GmbH1995-09-15
DPD DEFIBRILLATOR (K952085)Medical Research Laboratories, Inc.1995-06-05
UNIPOWER RECHARGEABLE BATTERY PACK (K940842)Unipower Corp.1994-09-07
NCE REPLACEMENT BATTERIES (K941995)National Custom Ent., Inc.1994-07-26
PEDIATRIC DEFIB K-PADS (K935083)Katecho, Inc.1994-07-25
UNIPOWERR RECHARGEABLE BATTERY PACK (K935111)Unipower Corp.1994-03-28
VITAL-COMBO(R) (K922315)Physio-Control Corp.1994-03-16
RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB (K934015)Portable Power Systems, Inc.1994-02-17
BATTERY PACK# S1024NC (K934508)Portable Power Systems, Inc.1994-02-17
BATTERY PACK #1012NC (K931266)Portable Power Systems, Inc.1994-02-03
LIFEPAK 9 DEFIBRILLATOR/MONITOR (K935674)Physio-Control Corp.1993-12-16
ZOLL PD 5300 (K931787)Zoll Medical Corp1993-10-15
5200 ADULT SOLID GEL MULTI-FUNCTION ELECTRODES (K931803)Zoll Medical Corp1993-10-08
ZOLL D 5400 ADULT SOLID GEL DEFIBRILLATION ELECTRO (K931804)Zoll Medical Corp1993-10-08
ZOLL PD 5200C ADULT SOLID GEL MULTI-FUNCTION ELECT (K931805)Zoll Medical Corp1993-10-08
CARDIAC THERAPHY SYSTEM SCP 900 (K921666)Ppg Hellige B.V.1993-09-23
DPD DEFIBRILLATOR (K930548)Medical Research Laboratories, Inc.1993-06-25
LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER (K931053)Physio-Control Corp.1993-05-18
PRIMEDIC DEFIBRILLATORS-N/B (K921765)Metronic Electronic GmbH1993-03-03
MARQUETTE SERIES 360 DEFIBRILLATOR (K921487)Marquette Electronics, Inc.1992-12-29
BATTERY PACK (K923864)Portable Power Systems, Inc.1992-10-05
MODEL #340 STEALTH-TRODE+LS (K923297)Cardiotronics, Inc.1992-09-18
LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR) (K922563)Raco Products Co.1992-07-28
LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR) (K920990)Raco Products Co.1992-07-06
MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE (K922227)Cardiotronics, Inc.1992-06-11
MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) (K922172)Cardiotronics, Inc.1992-06-11
MODEL # 830 ST ADULT STIMULATION PADS (STERILE) (K922173)Cardiotronics, Inc.1992-06-11
MODEL #125 CHILD STIMULATION PADS (K921606)Cardiotronics, Inc.1992-05-26
PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG (K912966)Physio-Control Corp.1992-02-21
SHOCK-PATCH ADULT DEFIBRILLATION PADS (K920086)Cardiotronics, Inc.1992-02-03
ZOLL D-900 DEFIBRILLATOR (K913484)Zmi Corp.1991-12-16
ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION (K914458)Medical Data Electronics1991-12-09
TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION (K914971)Nihon Kohden America, Inc.1991-12-04
MODEL #911 STEALTH MULTI PADS (K912621)Cardiotronics, Inc.1991-10-16
MODEL #110 STEALTH-TRODE CHILD DEFIB PADS (K911456)Cardiotronics, Inc.1991-10-16
MODEL #100 SHOCK-TRODE CHILD DEFIB PADS (K911455)Cardiotronics, Inc.1991-10-16
MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS (K911662)Marquette Electronics, Inc.1991-10-10
MODEL #350 SHOCK-PLATE DEFIB ADAPTOR (K911402)Cardiotronics, Inc.1991-10-03
MDPHONE CELLULAR + RESCUE (DEFIB SYSTEM) (K911604)Medphone Corp.1991-09-23
ESCORT 300 SERIES (K911665)Medical Data Electronics1991-08-29
K-FREE (K912587)Katecho, Inc.1991-07-30
DC200 DEFIBRILLATOR (K910634)Siemens Burdick, Inc.1991-07-24
12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON (K910144)Physio-Control Corp.1991-07-17
MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION (K910754)Hewlett-Packard Co.1991-05-08
DEFIBRILLATOR LEAD ADAPTER (K905065)Spacelabs, Inc.1991-04-12
MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR (K902288)Physio-Control Corp.1991-02-25
MODEL #250 DEFIB CABLE (K904466)Cardiotronics, Inc.1991-01-30
SERIES 1500 RESPONDER (K902782)Marquette Electronics, Inc.1991-01-18
FIRST MEDIC MODEL 510 (K896903)Spacelabs, Inc.1990-12-27
LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED (K905510)Physio-Control Corp.1990-12-20
MODEL #210 STEALTH DEFIB PADS (K904462)Cardiotronics, Inc.1990-12-03
MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002 (K903018)Medtronic Andover Medical, Inc.1990-12-03
LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR (K902478)Physio-Control Corp.1990-10-31
MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE (K902429)Laerdal Mfg. Corp.1990-09-27
MODEL 610 MODIFIED (K903657)First Medical Devices Corp.1990-09-04
THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT (K902590)Marquette Electronics, Inc.1990-07-18
LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES) (K895379)Physio-Control Corp.1990-02-26
LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER (K895533)Matrix Medica, Inc.1990-01-26
MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE (K900169)Laerdal Mfg. Corp.1990-01-26
DEFIB K-PADS (K895662)Katecho, Inc.1990-01-18
GEL-TAC(R) (K895009)Padeco, Inc.1989-12-13
DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB. (K894356)Phycon1989-12-13
MARQUETTE 1200 DEFIBRILLATION PADS (K895651)Marquette Electronics, Inc.1989-12-12
DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT. (K894355)Phycon1989-12-12
FIRST MEDIC MODEL 610P (K895185)First Medical Devices Corp.1989-10-27
COORDINATOR (K895113)Cardiotronics, Inc.1989-10-26
P POLYMER (K893990)Pace West1989-10-12
ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES (K895032)Zmi Corp.1989-10-12
DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE. (K891122)Big Valley Medical1989-09-13
MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE (K893403)Hewlett-Packard Co.1989-08-03
HEARTSTART 2000 DEFIBRILLATION ELECTRODE (K885186)Laerdal Mfg. Corp.1989-02-23
LIFEPAK 10 DEFIBRILLATOR/MONITOR (K890079)Physio-Control Corp.1989-02-23
LIFEPAK 50 MONITOR/DEFIBRILLATOR (K883617)Physio-Control Corp.1988-12-28
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Every clearance here is in the API, with alerts when new ones post.