MOD · Class II · 21 CFR 868.5895

FDA Product Code MOD: Accessory To Continuous Ventilator (respirator)

Leading manufacturers include Breas Medical AB, Corvent Medical, Inc. and Respironics, Inc..

14
Total
14
Cleared
261d
Avg days
1995
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 198d recently vs 272d historically

FDA 510(k) Cleared Accessory To Continuous Ventilator (respirator) Devices (Product Code MOD)

14 devices
1–14 of 14
Cleared May 12, 2026
CorVision® (91-205-Z0014)
K260051
Corvent Medical, Inc.
Anesthesiology · 124d
Cleared May 20, 2025
EveryWare
K242485
Breas Medical AB
Anesthesiology · 272d
Cleared Feb 17, 2017
Care Cycle Connect Application
K161411
Respironics, Inc.
Anesthesiology · 273d

About Product Code MOD - Regulatory Context

510(k) Submission Activity

14 total 510(k) submissions under product code MOD since 1995, with 14 receiving FDA clearance (average review time: 261 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MOD Product Code

Recent submissions under MOD have taken an average of 198 days to reach a decision - down from 272 days historically, suggesting improved FDA processing for this classification.

MOD devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →