DeviceClearance

Product code DQA— Cardiovascular

Pulse Oximeter

Classification name
Oximeter
Device class
Class 2
Regulation
21 CFR 870.2700
Advisory panel
Cardiovascular
Total cleared
727
First cleared
Most recent

Market context for product code DQA

FDA has cleared 727 devices under product code DQA between 1978 and 2026, filed by 271 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 DQA

Adverse events under product code DQA

product code DQA
Death
66
Malfunction
2,867
Other
1
Total
2,934

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 DQA

1–100 of 727

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