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Innolitics
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Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
IYM
System, Telethermographic, Infrared
3
Product Code
KXZ
System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
3
Product Code
KYA
System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
1
Product Code
K
90
0404
VARICOSCREEN(TM)
1
Cleared 510(K)
K
83
2989
BREAST THERMAL ACTIVITY INDICATOR
1
Cleared 510(K)
K
82
3245
THERMAX; THERMAX SYSTEM
1
Cleared 510(K)
K
82
1524
CHIROPRATIC INFRA-RED CRYSTAL PAK
1
Cleared 510(K)
K
82
1049
PARATHERM
1
Cleared 510(K)
LHM
System, Thermographic, Liquid Crystal
1
Product Code
LHP
System, Telethermographic (Sole Diagnostic Screen)
3
Product Code
LHQ
System, Telethermographic (Adjunctive Use)
1
Product Code
LHR
System, Thermographic, Liquid Crystal (Sole Diagnostic Screen)
3
Product Code
LXE
Doppler, Fetal, Ultrasound
2
Product Code
MAA
Monitor, Fetal Doppler Ultrasound
2
Product Code
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 25 January 2026 at 3:41 am
RA
/
subpart-c—obstetrical-and-gynecological-monitoring-devices
/
KYA
/
K821049
View Source
PARATHERM
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K821049
510(k) Type
Traditional
Applicant
AMERICAN THERMOMETER COMPANY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/29/1982
Days to Decision
23 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
IYM
System, Telethermographic, Infrared
KXZ
System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
KYA
System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
K
90
0404
VARICOSCREEN(TM)
K
83
2989
BREAST THERMAL ACTIVITY INDICATOR
K
82
3245
THERMAX; THERMAX SYSTEM
K
82
1524
CHIROPRATIC INFRA-RED CRYSTAL PAK
K
82
1049
PARATHERM
LHM
System, Thermographic, Liquid Crystal
LHP
System, Telethermographic (Sole Diagnostic Screen)
LHQ
System, Telethermographic (Adjunctive Use)
LHR
System, Thermographic, Liquid Crystal (Sole Diagnostic Screen)
LXE
Doppler, Fetal, Ultrasound
MAA
Monitor, Fetal Doppler Ultrasound
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous Devices
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
subpart-c—obstetrical-and-gynecological-monitoring-devices
/
KYA
/
K821049
View Source
PARATHERM
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K821049
510(k) Type
Traditional
Applicant
AMERICAN THERMOMETER COMPANY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/29/1982
Days to Decision
23 days