MOD

Accessory To Continuous Ventilator (Respirator)

Product code
MOD
Device name
Accessory To Continuous Ventilator (Respirator)
Device class
Class 2
21 CFR
21 CFR 868.5895
Medical specialty
Anesthesiology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
16

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-08-27.

NumberDecision dateApplicantDevice nameSummary
K2613602026-08-27Resmed CorpEasyCare Tx 2PDF
K2538072026-08-20Convergence Medical Sciences , Ltd.Valence InVent Xtend™ (CVG-4101-VXA)PDF
K2600512026-05-12CorVent® Medical, Inc.CorVision® (91-205-Z0014)PDF
K2424852025-05-20Breas Medical ABEveryWarePDF

4 summaries are archived here for direct download.

Official FDA classification page: MOD
Classification and pathway per current FDA publications. Data from openFDA (CC0).