DeviceClearance

Product code BZK— Anesthesiology

ExSpiron 1Xi

Classification name
Spirometer, Monitoring (W/Wo Alarm)
Device class
Class 2
Regulation
21 CFR 868.1850
Advisory panel
Anesthesiology
Total cleared
61
First cleared
Most recent

Market context for product code BZK

FDA has cleared 61 devices under product code BZK between 1976 and 2019, filed by 38 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 BZK

Adverse events under product code BZK

product code BZK
Death
2
Total
2

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 BZK

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