FDA Product Code OLK: Pulse Oximeter For Over-the-counter Use
Non-wearable, Fingertip Pulse Oximeter Intended For Over-the-counter Use For Non-continuous Monitoring
Leading manufacturers include Nonin Medical, Inc. and Masimo Corporation.
FDA 510(k) Cleared Pulse Oximeter For Over-the-counter Use Devices (Product Code OLK)
About Product Code OLK - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code OLK since 2024, with 2 receiving FDA clearance (average review time: 1021 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under OLK have taken an average of 1279 days to reach a decision - up from 762 days historically. Manufacturers should account for longer review timelines in current project planning.
OLK devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →