DeviceClearance

Product code BYE— Anesthesiology

PEEP VALVE

Classification name
Attachment, Breathing, Positive End Expiratory Pressure
Device class
Class 2
Regulation
21 CFR 868.5965
Advisory panel
Anesthesiology
Total cleared
80
First cleared
Most recent

Market context for product code BYE

FDA has cleared 80 devices under product code BYE between 1976 and 2016, filed by 56 applicant companies. 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.

Clearances per year

last 15 years

Top applicants under product code BYE

Adverse events under product code BYE

product code BYE
Death
5
Total
5

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code BYE

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