DeviceClearance

Product code QFB— General Hospital

ClearMate

Classification name
Isocapnic Ventilation Device
Device class
Class 2
Regulation
21 CFR 868.5480
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

“An isocapnic ventilation device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags (21 CFR 868.5320), oxygen cannulas (21 CFR 868.5340), masks (21 CFR 868.5550), valves (21 CFR 868.5870), resuscitation bags (21 CFR 868.5915), and/or tubing (21 CFR 868.5925).”

— U.S. Food and Drug Administration, device classification record for product code QFB under 21 CFR 868.5480, via openFDA

Market context for product code QFB

FDA has cleared 1 device under product code QFB, all in 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QFB

Recent clearances under product code QFB

Data sourced from openFDA. This site is unofficial and independent of the FDA.