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FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular Diagnostic Devices
CFR Sub-Part
Cardiovascular Monitoring Devices
CFR Sub-Part
QLS
Pulse Oximeter For Low-Acuity Settings
2
Product Code
PGJ
Oximeter, Wellness
2
Product Code
DPZ
Oximeter, Ear
2
Product Code
DQA
Oximeter
2
Product Code
K
21
2752
Med-link Pulse Oximeter
2
Cleared 510(K)
K
21
2555
Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC
2
Cleared 510(K)
K
21
2153
Biobeat Platform, BB-613WP Patch
2
Cleared 510(K)
K
21
1140
Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult
2
Cleared 510(K)
K
21
2300
Pulse Oximeter
2
Cleared 510(K)
K
21
1400
Pulse Oximeter
2
Cleared 510(K)
K
21
1632
Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)
2
Cleared 510(K)
K
21
0305
Pulse Oximeter
2
Cleared 510(K)
K
21
1407
Belun Ring BLR-100X
2
Cleared 510(K)
K
21
2876
Carescape SpO2 - Masimo
2
Cleared 510(K)
Show All 664 Submissions
NLF
Oximeter, Reprocessed
2
Product Code
Cardiovascular Therapeutic Devices
CFR Sub-Part
Diagnostic Devices
CFR Sub-Part
Miscellaneous
CFR Sub-Part
Monitoring Devices
CFR Sub-Part
Neurological Therapeutic Devices
CFR Sub-Part
Physical Medicine Therapeutic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
Cardiovascular
Review Panel
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 2 June 2023 at 11:04 pm
AN
/
cardiovascular-monitoring-devices
/
DQA
/
K212876
View Source
Carescape SpO2 - Masimo
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212876
510(k) Type
Special
Applicant
Masimo Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/8/2021
Days to Decision
29 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular Diagnostic Devices
Cardiovascular Monitoring Devices
QLS
Pulse Oximeter For Low-Acuity Settings
PGJ
Oximeter, Wellness
DPZ
Oximeter, Ear
DQA
Oximeter
K
21
2752
Med-link Pulse Oximeter
K
21
2555
Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC
K
21
2153
Biobeat Platform, BB-613WP Patch
K
21
1140
Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult
K
21
2300
Pulse Oximeter
K
21
1400
Pulse Oximeter
K
21
1632
Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)
K
21
0305
Pulse Oximeter
K
21
1407
Belun Ring BLR-100X
K
21
2876
Carescape SpO2 - Masimo
Show All 664 Submissions
NLF
Oximeter, Reprocessed
Cardiovascular Therapeutic Devices
Diagnostic Devices
Miscellaneous
Monitoring Devices
Neurological Therapeutic Devices
Physical Medicine Therapeutic Devices
Prosthetic Devices
Surgical Devices
Therapeutic Devices
Cardiovascular
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
AN
/
cardiovascular-monitoring-devices
/
DQA
/
K212876
View Source
Carescape SpO2 - Masimo
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212876
510(k) Type
Special
Applicant
Masimo Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/8/2021
Days to Decision
29 days
Submission Type
Summary