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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
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Review Panel
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Review Panel
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Review Panel
General Hospital
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 C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
FLK
Thermometer, Clinical Mercury
2
Product Code
K
96
0185
AMSINO CLINICAL THERMOMETER
2
Cleared 510(K)
K
96
0224
GERATHERM MERCUIRY FREE CLINICAL THERMOMETER
2
Cleared 510(K)
K
95
3465
KENTEMP
2
Cleared 510(K)
K
94
2483
CLINICAL GLASS THERMOMETER
2
Cleared 510(K)
K
94
1673
MEDIAID UNIVERSAL THERMOMETER
2
Cleared 510(K)
K
94
0394
AMG MED BRAND CLINICAL GLASS THERMOMETER
2
Cleared 510(K)
K
94
0380
AMG MED BRAND CLINICAL GLASS THERMOMETER
2
Cleared 510(K)
K
93
2991
GUARDIAN AND ANDINO MODELS
2
Cleared 510(K)
K
92
3225
LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME
2
Cleared 510(K)
K
91
3793
SIMPEX INC. ORAL AND RECTAL THERMOMETERS
2
Cleared 510(K)
K
91
1269
MERCURY AND GLASS FEVER THERMOMETER
2
Cleared 510(K)
K
90
2625
CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT
2
Cleared 510(K)
K
90
3500
MASCOT THERMOTER
2
Cleared 510(K)
K
90
1790
THERMOMETER, MERCURY/CLINICAL
2
Cleared 510(K)
K
90
0646
MERCURY THERMOMETERS (ORAL AND RECTAL)
2
Cleared 510(K)
K
89
7054
CLINICAL MERCURY THERMOMETER
2
Cleared 510(K)
K
89
3602
GLASS MERCURY FILLED THERMOMETERS
2
Cleared 510(K)
K
88
3573
THERMOMETER, MERCURY/CLINICAL
2
Cleared 510(K)
K
87
0285
THERMOMETER SHEATHES, STERILE (GLASS)
2
Cleared 510(K)
K
85
2301
INOX THERMOMETER JAR
2
Cleared 510(K)
K
82
2502
DISPOSABLE THERMOMETERS
2
Cleared 510(K)
K
81
3423
THERMOMETER SHEATHS
2
Cleared 510(K)
K
81
3424
THERMOMETERS
2
Cleared 510(K)
K
81
1631
THERMOMETER (MADE IN CHINA)
2
Cleared 510(K)
K
80
1791
FERTILITY AWARENESS METHOD KIT
2
Cleared 510(K)
K
79
2426
DISPOSABLE TEMPERATURE PROBE
2
Cleared 510(K)
K
79
0891
TEMPO2-II DISPOSABLE THERMOMETERS
2
Cleared 510(K)
K
78
1817
OVU-GUIDE
2
Cleared 510(K)
K
78
1106
THERMOMETER, EXACTA TEMP
2
Cleared 510(K)
K
78
0591
THERMOMETER KIT
2
Cleared 510(K)
K
77
2365
THERMOMETER SHEATHS
2
Cleared 510(K)
K
77
0125
DISPOS-A-CARE THERMOMETER SHEATH
2
Cleared 510(K)
K
76
0552
THERMOMETER STAND AND DUST COVER
2
Cleared 510(K)
CAR
Monitor, Spinal-Fluid Pressure, Electrically Powered
2
Product Code
FLL
Thermometer, Electronic, Clinical
2
Product Code
FLN
Monitor, Electric For Gravity Flow Infusion Systems
2
Product Code
FMJ
Manometer, Spinal-Fluid
2
Product Code
FQA
Scale, Surgical Sponge
1
Product Code
FQZ
Thermometer, Clinical Color Change
1
Product Code
FRC
Indicator, Biological Sterilization Process
2
Product Code
FRI
Scale, Stand-On, Patient
1
Product Code
FRW
Scale, Patient
1
Product Code
JOJ
Indicator, Physical/Chemical Sterilization Process
2
Product Code
KMI
Monitor, Bed Patient
1
Product Code
KPD
Strip, Temperature, Forehead, Liquid Crystal
2
Product Code
LHB
Timer, Apgar
1
Product Code
LRT
Indicator, Sterilization
2
Product Code
MRB
Indicator, Biological, Liquid Chemical Sterilization Process
2
Product Code
MRL
Scale, Sponge, Surgical, Electrically-Powered
1
Product Code
MTC
Indicator, Chemical, Enzymatic, Sterilization Process
2
Product Code
OCI
Indicator, Physical/Chemical, Storage Temperature
2
Product Code
OZK
Thermometer, Exhaled Breath
2
Product Code
PJO
Fall Prevention Alarm/Sensor Combination Attached Or Unattached
1
Product Code
PJP
Fall Prevention Alarm/Sensor Attached Only
1
Product Code
PWW
Fever Monitoring Kit
2
Product Code
PXH
Thermometer Kit
2
Product Code
QKM
A Chemical Vapor Sterilization Multivariable Chemical Indicator
2
Product Code
SBO
Bed-Patient Activity Monitoring System
1
Product Code
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
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
HO
/
subpart-c—general-hospital-and-personal-use-monitoring-devices
/
FLK
/
K792426
View Source
DISPOSABLE TEMPERATURE PROBE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K792426
510(k) Type
Traditional
Applicant
HOSPITAK, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/16/1980
Days to Decision
49 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
FLK
Thermometer, Clinical Mercury
K
96
0185
AMSINO CLINICAL THERMOMETER
K
96
0224
GERATHERM MERCUIRY FREE CLINICAL THERMOMETER
K
95
3465
KENTEMP
K
94
2483
CLINICAL GLASS THERMOMETER
K
94
1673
MEDIAID UNIVERSAL THERMOMETER
K
94
0394
AMG MED BRAND CLINICAL GLASS THERMOMETER
K
94
0380
AMG MED BRAND CLINICAL GLASS THERMOMETER
K
93
2991
GUARDIAN AND ANDINO MODELS
K
92
3225
LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME
K
91
3793
SIMPEX INC. ORAL AND RECTAL THERMOMETERS
K
91
1269
MERCURY AND GLASS FEVER THERMOMETER
K
90
2625
CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT
K
90
3500
MASCOT THERMOTER
K
90
1790
THERMOMETER, MERCURY/CLINICAL
K
90
0646
MERCURY THERMOMETERS (ORAL AND RECTAL)
K
89
7054
CLINICAL MERCURY THERMOMETER
K
89
3602
GLASS MERCURY FILLED THERMOMETERS
K
88
3573
THERMOMETER, MERCURY/CLINICAL
K
87
0285
THERMOMETER SHEATHES, STERILE (GLASS)
K
85
2301
INOX THERMOMETER JAR
K
82
2502
DISPOSABLE THERMOMETERS
K
81
3423
THERMOMETER SHEATHS
K
81
3424
THERMOMETERS
K
81
1631
THERMOMETER (MADE IN CHINA)
K
80
1791
FERTILITY AWARENESS METHOD KIT
K
79
2426
DISPOSABLE TEMPERATURE PROBE
K
79
0891
TEMPO2-II DISPOSABLE THERMOMETERS
K
78
1817
OVU-GUIDE
K
78
1106
THERMOMETER, EXACTA TEMP
K
78
0591
THERMOMETER KIT
K
77
2365
THERMOMETER SHEATHS
K
77
0125
DISPOS-A-CARE THERMOMETER SHEATH
K
76
0552
THERMOMETER STAND AND DUST COVER
CAR
Monitor, Spinal-Fluid Pressure, Electrically Powered
FLL
Thermometer, Electronic, Clinical
FLN
Monitor, Electric For Gravity Flow Infusion Systems
FMJ
Manometer, Spinal-Fluid
FQA
Scale, Surgical Sponge
FQZ
Thermometer, Clinical Color Change
FRC
Indicator, Biological Sterilization Process
FRI
Scale, Stand-On, Patient
FRW
Scale, Patient
JOJ
Indicator, Physical/Chemical Sterilization Process
KMI
Monitor, Bed Patient
KPD
Strip, Temperature, Forehead, Liquid Crystal
LHB
Timer, Apgar
LRT
Indicator, Sterilization
MRB
Indicator, Biological, Liquid Chemical Sterilization Process
MRL
Scale, Sponge, Surgical, Electrically-Powered
MTC
Indicator, Chemical, Enzymatic, Sterilization Process
OCI
Indicator, Physical/Chemical, Storage Temperature
OZK
Thermometer, Exhaled Breath
PJO
Fall Prevention Alarm/Sensor Combination Attached Or Unattached
PJP
Fall Prevention Alarm/Sensor Attached Only
PWW
Fever Monitoring Kit
PXH
Thermometer Kit
QKM
A Chemical Vapor Sterilization Multivariable Chemical Indicator
SBO
Bed-Patient Activity Monitoring System
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HO
/
subpart-c—general-hospital-and-personal-use-monitoring-devices
/
FLK
/
K792426
View Source
DISPOSABLE TEMPERATURE PROBE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K792426
510(k) Type
Traditional
Applicant
HOSPITAK, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/16/1980
Days to Decision
49 days