FDA Browser
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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
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
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
CAH
Filter, Bacterial, Breathing-Circuit
2
Product Code
MAJ
Catheter, Percutaneous, Intraspinal, Short Term
2
Product Code
OFP
Anesthesia Breathing Circuit Kit (Adult & Pediatric)
1
Product Code
LEY
Set, Oral Administration
2
Product Code
NIH
Disinfectant, Subsystem, Water Purification
2
Product Code
NII
Disinfectant, Dialysate Delivery System
2
Product Code
FLJ
Unit, Airflow, Laminar
2
Product Code
FRT
Unit, Isolation, Surgical
2
Product Code
FYD
Apparatus, Exhaust, Surgical
2
Product Code
ORC
Air Filter Portable Apparatus
2
Product Code
K
19
0027
SteriStay
2
Cleared 510(K)
K
17
3349
Operio
2
Cleared 510(K)
K
16
3455
SurgiCube
2
Cleared 510(K)
K
15
3498
Operio
2
Cleared 510(K)
K
12
3006
AIR BARRIER SYSTEM (ABS)
2
Cleared 510(K)
K
09
2801
ABS BLOWER, ABS NOZZLE, MODEL 1001
2
Cleared 510(K)
QGI
Air-Handling Apparatus Accessory
1
Product Code
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 27 June 2025 at 11:06 pm
HO
/
subpart-f—therapeutic-devices
/
ORC
/
K190027
View Source
SteriStay
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...
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
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
CAH
Filter, Bacterial, Breathing-Circuit
MAJ
Catheter, Percutaneous, Intraspinal, Short Term
OFP
Anesthesia Breathing Circuit Kit (Adult & Pediatric)
LEY
Set, Oral Administration
NIH
Disinfectant, Subsystem, Water Purification
NII
Disinfectant, Dialysate Delivery System
FLJ
Unit, Airflow, Laminar
FRT
Unit, Isolation, Surgical
FYD
Apparatus, Exhaust, Surgical
ORC
Air Filter Portable Apparatus
K
19
0027
SteriStay
K
17
3349
Operio
K
16
3455
SurgiCube
K
15
3498
Operio
K
12
3006
AIR BARRIER SYSTEM (ABS)
K
09
2801
ABS BLOWER, ABS NOZZLE, MODEL 1001
QGI
Air-Handling Apparatus Accessory
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-f—therapeutic-devices
/
ORC
/
K190027
View Source
SteriStay
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...