Product code DRO— Cardiovascular
300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER
- Classification name
- Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- Device class
- Class 2
- Regulation
- 21 CFR 870.5550
- Advisory panel
- Cardiovascular
- Total cleared
- 84
- First cleared
- Most recent
Market context for product code DRO
FDA has cleared devices under product code DRO between 1982 and 2001, filed by 30 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
- 1995
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
Top applicants under product code DRO
Recent clearances under product code DRO
- K012218 — LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
- K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
- K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
- K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
- K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
- K974034 — PORTABLE INTENSIVE CARE UNIT
- K962547 — CARDIOSERV P
- K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM
- K961138 — ESORT II + 400 SERIES MONITOR
- K950856 — ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000
- K951593 — LIFEPAK 11
- K950483 — HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR
- K926175 — K-DEFIB/PACE CARBON ELECTRODE
- K915757 — MODELS M1722A, M1723A, M1724A DEFIBRILLATORS
- K915328 — GEL-TAC
- K914955 — K-DEFIB/PACE ELECTRODE
- K912599 — QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC
- K911956 — ZOLL PD-1400 PACER/DEFIBRILLATOR
- K910661 — MODEL 205 SHOCK-TRODE
- K903437 — DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER
- K894492 — NKA MODEL SEC-3102 CARDIAC STIMULATOR
- K894588 — DEFIB/PACING PADS
- K895728 — R2 PACE ADAPTOR CABLE, MODEL 196
- K895729 — R2 PACE PAD, MODEL 480
- K885166 — ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES
- K885171 — MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE
- K880932 — MRL PACETTE, 450SLL
- K884532 — TRIAD-EP II, PUSHBUTTON, CABLE INPUT
- K884530 — TRIAD-EP II, PLATE INPUT
- K883178 — TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE
- K883304 — TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY
- K883523 — TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE
- K883121 — QUIK-PACE II ELECTRODES
- K882338 — MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE
- K883375 — MODEL #918 MULTI-PADS
- K882168 — EXTERNAL PACEMAKER 2000 (EP2000)
- K880936 — TRIAD-EP
- K874447 — DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC
- K871751 — QUIK-PACE NONINVASIVE PACEMAKER
- K874090 — 300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER
- K873402 — ZOLL NTP-1200 PACER/DEFIBRILLATOR
- K872778 — PACESTART
- K872368 — MODIFIED VERSA STIM ELECTRODE LINE
- K872012 — LECTEC NON-INVASIVE PACING ELECTRODE
- K871538 — STAT-PAD (TM)
- K871971 — MODIFIED PACE*AID MODEL 53
- K871569 — MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR
- K871176 — PACE 10 NON-INVASIVE EXTERNAL PACEMAKER
- K864985 — DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE
- K864986 — ETP 300 NON-INVASIVE EXTERNAL PACEMAKER
- K864987 — DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE
- K864988 — ETP 180E NON-INVASIVE EXTERNAL PACEMAKER
- K864989 — ETP 180A NON-INVASIVE EXTERNAL PACEMAKER
- K863547 — MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE
- K862298 — ALTERNATE SIZE E-Z-PACE ELECTRODE
- K854196 — DCI MODEL EP-2 CLINICAL STIMULATOR
- K860551 — ETP 180 CARDIAC PACEMAKER (EXTERNAL)
- K855015 — NONINVASIVE TEMP. PACEMAKER NTP-1000
- K860283 — AMI CARDIO-PAD
- K854924 — AMI E-Z-PACE ELECTODE
- K854853 — NI-PACER 1
- K854117 — AMENDMENT LIFEPAK 8, NPN 052
- K854233 — CMI 3000
- K853732 — LIFEPAK 8 MODIFICATION
- K850812 — EMERGIPACE - EXTERNAL PACEMAKER
- K852958 — PACEPAC
- K850791 — MDI 2000 - PULSE GENERATOR
- K851247 — AMENDMENT LIFEPAK 200, NPN 046
- K851248 — AMENDMENT LIFEPAK 100, NPN 045
- K850596 — PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY &
- K850170 — HEART AID MODEL 97
- K844811 — PACE AID MODEL 53
- K843547 — PACE *AID MODEL 52
- K843358 — HEART-AID MODEL 80
- K840353 — PACEMAKER PULSE GENERATOR W/ELECTRODE
- K834262 — TRANS-PACE
- K840047 — LIFEPAK 7D
- K832876 — LIFEPAK 7P
- K820507 — PACE* AID MODEL 50
- K820609 — HEART *AID, #80
- K821152 — HEART AID #90
- K821673 — HEART*AID, ALS, MODEL 95
- K822246 — NONINVASIVE TEMPORARY PACEMAKER
- K813553 — PACE *AID
Data sourced from openFDA. This site is unofficial and independent of the FDA.