FDA Product Code MOD: Accessory To Continuous Ventilator (respirator)
Leading manufacturers include Breas Medical AB.
FDA 510(k) Cleared Accessory To Continuous Ventilator (respirator) Devices (Product Code MOD)
About Product Code MOD - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code MOD since 1995, with 13 receiving FDA clearance (average review time: 272 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for MOD submissions have been consistent, averaging 272 days recently vs 272 days historically.
MOD devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →