Atlas FDA

LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES

FDA 510(k) clearance K012218 · decided 2001-10-12

Clearance details

K-number
K012218
Device name
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
Applicant
The Ludlow Company LP
Decision
Substantially Equivalent
Date received
2001-07-16
Decision date
2001-10-12
Days to decision
88 days
Clearance type
Traditional
Product code
DRO
Device class
2
Regulation number
870.5550
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Chicopee, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (K012404)Katecho, Inc.2001-10-12
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 (K000660)Medical Data Electronics2000-03-28
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (K983196)Tz Medical, Inc.1999-09-15
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT (K983232)Tz Medical, Inc.1999-09-15
PORTABLE INTENSIVE CARE UNIT (K974034)Medical Research Laboratories, Inc.1998-03-02
CARDIOSERV P (K962547)Marquette Electronics, Inc.1997-03-06
RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (K963120)Marquette Electronics, Inc.1997-02-28
ESORT II + 400 SERIES MONITOR (K961138)Medical Data Electronics1996-12-10
ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 (K950856)Zoll Medical Corp1995-12-29
LIFEPAK 11 (K951593)Physio-Control Corp.1995-12-29
HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR (K950483)Hewlett-Packard Co.1995-05-22
K-DEFIB/PACE CARBON ELECTRODE (K926175)Katecho, Inc.1993-04-15

Recalls involving this device

RecordFirmDate
MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC recall (Z-2545-2015)Covidien LLC2015-09-02
MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22 recall (Z-2546-2015)Covidien LLC2015-09-02
Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Ra recall (Z-0043-2015)Covidien LLC2014-10-15
Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected P recall (Z-0044-2015)Covidien LLC2014-10-15
Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660 recall (Z-0045-2015)Covidien LLC2014-10-15
Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A recall (Z-0048-2015)Covidien LLC2014-10-15
Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Int recall (Z-1184-2013)Covidien LLC2013-04-29
Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. recall (Z-1185-2013)Covidien LLC2013-04-29