FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
Subpart E—Cardiovascular Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
DRK
Dc-Defibrillator, High Energy, (Including Paddles)
3
Product Code
DRL
Tester, Defibrillator
2
Product Code
DRM
Compressor, Cardiac, External
2
Product Code
K
22
1700
AutoPulse NXT Resuscitation System
2
Cleared 510(K)
K
21
1289
RMU-2000 Automated Chest Compression System
2
Cleared 510(K)
K
17
3553
LUCAS 3 Chest Compression System
2
Cleared 510(K)
K
16
1768
LUCAS 3 Chest Compression System
2
Cleared 510(K)
K
15
3628
ROSC-U Mini Chest Compressor (RMCC)
2
Cleared 510(K)
K
14
1809
RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
2
Cleared 510(K)
K
11
2998
AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
2
Cleared 510(K)
K
10
2068
MINIATURIZE CHEST COMPRESSOR (MCC)
2
Cleared 510(K)
K
09
0422
LUCAS 2
2
Cleared 510(K)
K
07
2527
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
2
Cleared 510(K)
K
07
3079
THUMPER, MODEL: 1008
2
Cleared 510(K)
K
06
3602
AUTOPULSE RESUSCITATION SYSTEM MODEL100
2
Cleared 510(K)
K
06
2401
MODIFICATION TO LUCAS
2
Cleared 510(K)
K
06
2119
HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
2
Cleared 510(K)
K
05
3403
LUCAS
2
Cleared 510(K)
K
02
4215
ENERTRON CPR JACK
2
Cleared 510(K)
K
04
0453
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
2
Cleared 510(K)
K
03
2852
MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
2
Cleared 510(K)
K
02
2345
AUTOPULSE RESUSCITATION SYSTEM
2
Cleared 510(K)
K
01
1046
AUTOPULSE, MODEL 100
2
Cleared 510(K)
K
97
2525
THUMPER
2
Cleared 510(K)
K
96
2237
THUMPER CARDIOPULMONARY RESUSCITATOR
2
Cleared 510(K)
K
95
1124
CAD-2000 CARDIAC ASSIST DEVICE
2
Cleared 510(K)
K
92
2093
HASKEL CPR
2
Cleared 510(K)
K
87
1271
HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR.
2
Cleared 510(K)
K
87
1272
HUNTLEIGH FLOWPAC FP2000
2
Cleared 510(K)
K
85
5004
SWELL-RELIEF
2
Cleared 510(K)
K
85
4734
MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE
2
Cleared 510(K)
K
85
1139
THUMPER CARDIOPULMONARY RESUSCITATOR 1005
2
Cleared 510(K)
K
84
1275
FINE NEEDLE ASPIRATION DEVICE
2
Cleared 510(K)
K
84
1822
KEYMED SIGMOIDOSCOPE SUCTION UNIT
2
Cleared 510(K)
K
84
1410
BUSH NECK W/TAP
2
Cleared 510(K)
K
83
3879
CARDIOPULMONARY RESUSCITATOR
2
Cleared 510(K)
K
81
1987
OXY-QUIK MARK IV OXYGEN INHALATOR
2
Cleared 510(K)
K
81
1909
CARDIOPULMUNARY RESUSCITATOR
2
Cleared 510(K)
K
80
1945
SAVE MOR
2
Cleared 510(K)
K
80
1947
CPR TRAVELER
2
Cleared 510(K)
K
80
1946
CPR HELPER
2
Cleared 510(K)
K
79
2451
PNEUPAC RESUSCITATOR INSTANT ACTION SET
2
Cleared 510(K)
K
79
2458
PNEUPAC TEST SET, PT.#500-A250
2
Cleared 510(K)
K
79
2454
PNEUPAC RESUSCITATOR INSTANT ACTION SET
2
Cleared 510(K)
K
79
2452
PNEUPAC RESUSCITATOR INSTANT ACTION SET
2
Cleared 510(K)
K
79
1145
CPR CONTROL SYSTEM
2
Cleared 510(K)
K
79
0513
HLA-2000
2
Cleared 510(K)
K
76
1194
HLR QUICK-FIT HEART-LUNG RESUSCITATOR
2
Cleared 510(K)
DRN
Device, Counter-Pulsating, External
2
Product Code
DRO
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
2
Product Code
DRP
Tourniquet, Automatic Rotating
2
Product Code
DWJ
System, Thermal Regulating
2
Product Code
DXE
Catheter, Embolectomy
2
Product Code
DXF
Catheter, Septostomy
2
Product Code
JOW
Sleeve, Limb, Compressible
2
Product Code
LDD
Dc-Defibrillator, Low-Energy, (Including Paddles)
2
Product Code
LHX
Trousers, Anti-Shock
2
Product Code
LIX
Aid, Cardiopulmonary Resuscitation
2
Product Code
LOX
Catheters, Transluminal Coronary Angioplasty, Percutaneous
2
Product Code
MKJ
Automated External Defibrillators (Non-Wearable)
3
Product Code
MMX
Device, Percutaneous Retrieval
2
Product Code
MPC
Atrial Defibrillator
3
Product Code
MPD
Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
2
Product Code
MPE
Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker
2
Product Code
NSA
Over-The-Counter Automated External Defibrillator
3
Product Code
NZE
Hyperthermia Monitor
2
Product Code
PJB
Catheter Remote Control System
2
Product Code
PLA
Esophageal Thermal Regulation And Gastric Suctioning Device
2
Product Code
PMJ
Cpr Aid Feedback Device (No Software)
2
Product Code
PMK
Cpr Aid Device Without Feedback
1
Product Code
PPS
Sleeve, Head And Neck, Compressible
2
Product Code
QEW
Peripheral Mechanical Thrombectomy With Aspiration
2
Product Code
QEX
Coronary Mechanical Thrombectomy With Aspiration
2
Product Code
QEY
Mechanical Thrombolysis Catheter
2
Product Code
QEZ
Aspiration Thrombectomy Catheter
2
Product Code
QLZ
Septostomy Catheter, Reprocessed
2
Product Code
QMS
Adjunctive Open Loop Fluid Therapy Recommender
2
Product Code
Subpart F—Therapeutic Devices
CFR Sub-Part
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 9 May 2025 at 11:05 pm
CV
/
subpart-f—cardiovascular-therapeutic-devices
/
DRM
/
K761194
View Source
HLR QUICK-FIT HEART-LUNG RESUSCITATOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K761194
510(k) Type
Traditional
Applicant
MCKESSON CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/9/1976
Days to Decision
3 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
Subpart E—Cardiovascular Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
DRK
Dc-Defibrillator, High Energy, (Including Paddles)
DRL
Tester, Defibrillator
DRM
Compressor, Cardiac, External
K
22
1700
AutoPulse NXT Resuscitation System
K
21
1289
RMU-2000 Automated Chest Compression System
K
17
3553
LUCAS 3 Chest Compression System
K
16
1768
LUCAS 3 Chest Compression System
K
15
3628
ROSC-U Mini Chest Compressor (RMCC)
K
14
1809
RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
K
11
2998
AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
K
10
2068
MINIATURIZE CHEST COMPRESSOR (MCC)
K
09
0422
LUCAS 2
K
07
2527
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
K
07
3079
THUMPER, MODEL: 1008
K
06
3602
AUTOPULSE RESUSCITATION SYSTEM MODEL100
K
06
2401
MODIFICATION TO LUCAS
K
06
2119
HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
K
05
3403
LUCAS
K
02
4215
ENERTRON CPR JACK
K
04
0453
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
K
03
2852
MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
K
02
2345
AUTOPULSE RESUSCITATION SYSTEM
K
01
1046
AUTOPULSE, MODEL 100
K
97
2525
THUMPER
K
96
2237
THUMPER CARDIOPULMONARY RESUSCITATOR
K
95
1124
CAD-2000 CARDIAC ASSIST DEVICE
K
92
2093
HASKEL CPR
K
87
1271
HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR.
K
87
1272
HUNTLEIGH FLOWPAC FP2000
K
85
5004
SWELL-RELIEF
K
85
4734
MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE
K
85
1139
THUMPER CARDIOPULMONARY RESUSCITATOR 1005
K
84
1275
FINE NEEDLE ASPIRATION DEVICE
K
84
1822
KEYMED SIGMOIDOSCOPE SUCTION UNIT
K
84
1410
BUSH NECK W/TAP
K
83
3879
CARDIOPULMONARY RESUSCITATOR
K
81
1987
OXY-QUIK MARK IV OXYGEN INHALATOR
K
81
1909
CARDIOPULMUNARY RESUSCITATOR
K
80
1945
SAVE MOR
K
80
1947
CPR TRAVELER
K
80
1946
CPR HELPER
K
79
2451
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K
79
2458
PNEUPAC TEST SET, PT.#500-A250
K
79
2454
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K
79
2452
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K
79
1145
CPR CONTROL SYSTEM
K
79
0513
HLA-2000
K
76
1194
HLR QUICK-FIT HEART-LUNG RESUSCITATOR
DRN
Device, Counter-Pulsating, External
DRO
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
DRP
Tourniquet, Automatic Rotating
DWJ
System, Thermal Regulating
DXE
Catheter, Embolectomy
DXF
Catheter, Septostomy
JOW
Sleeve, Limb, Compressible
LDD
Dc-Defibrillator, Low-Energy, (Including Paddles)
LHX
Trousers, Anti-Shock
LIX
Aid, Cardiopulmonary Resuscitation
LOX
Catheters, Transluminal Coronary Angioplasty, Percutaneous
MKJ
Automated External Defibrillators (Non-Wearable)
MMX
Device, Percutaneous Retrieval
MPC
Atrial Defibrillator
MPD
Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
MPE
Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker
NSA
Over-The-Counter Automated External Defibrillator
NZE
Hyperthermia Monitor
PJB
Catheter Remote Control System
PLA
Esophageal Thermal Regulation And Gastric Suctioning Device
PMJ
Cpr Aid Feedback Device (No Software)
PMK
Cpr Aid Device Without Feedback
PPS
Sleeve, Head And Neck, Compressible
QEW
Peripheral Mechanical Thrombectomy With Aspiration
QEX
Coronary Mechanical Thrombectomy With Aspiration
QEY
Mechanical Thrombolysis Catheter
QEZ
Aspiration Thrombectomy Catheter
QLZ
Septostomy Catheter, Reprocessed
QMS
Adjunctive Open Loop Fluid Therapy Recommender
Subpart F—Therapeutic Devices
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
CV
/
subpart-f—cardiovascular-therapeutic-devices
/
DRM
/
K761194
View Source
HLR QUICK-FIT HEART-LUNG RESUSCITATOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K761194
510(k) Type
Traditional
Applicant
MCKESSON CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/9/1976
Days to Decision
3 days