FDA Product Code DQA: Oximeter
Continuous oxygen saturation monitoring is a cornerstone of safe patient care across clinical settings. FDA product code DQA covers pulse oximeters and oximeter systems.
These devices use near-infrared light to non-invasively measure the oxygen saturation of hemoglobin in arterial blood, providing a continuous, real-time assessment of respiratory status. They are standard equipment in operating rooms, intensive care units, and emergency departments worldwide.
DQA devices are Class II medical devices, regulated under 21 CFR 870.2700 and reviewed by the FDA Anesthesiology panel.
Leading manufacturers include Unimed Medical Supplies, Inc., Masimo Corporation and Beijing Choice Electronic Technology Co., Ltd..
FDA 510(k) Cleared Oximeter Devices (Product Code DQA)
About Product Code DQA - Regulatory Context
510(k) Submission Activity
724 total 510(k) submissions under product code DQA since 1978, with 724 receiving FDA clearance (average review time: 162 days).
Submission volume has remained relatively stable over the observed period, with 32 submissions in the last 24 months.
FDA Review Time
Recent submissions under DQA have taken an average of 234 days to reach a decision - up from 159 days historically. Manufacturers should account for longer review timelines in current project planning.
DQA devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →