MOD · Class II · 21 CFR 868.5895

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

Leading manufacturers include Cardiopulmonary Corp., Puritan Bennett Corp. and The Medical Device Group, Inc..

16
Total
16
Cleared
253d
Avg days
1995
Since
Growing category - 4 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 197d recently vs 272d historically

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

16 devices
1–16 of 16
Cleared Aug 27, 2026
EasyCare Tx 2
K261360
ResMed Corp
Anesthesiology · 125d
Cleared Aug 20, 2026
Valence InVent Xtend™ (CVG-4101-VXA)
K253807
Convergence Medical Sciences , Ltd.
Anesthesiology · 265d
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
Cleared Aug 14, 2009
BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE
K091461
Cardiopulmonary Corp.
Anesthesiology · 88d
Cleared Dec 23, 2005
VENTLINK SYSTEM
K052751
Mediserve Information Systems, Inc.
Anesthesiology · 84d
Cleared Oct 13, 2005
IISIS, VERSION 1.0
K052244
Innovision Medical Technologies, LLC
Anesthesiology · 57d
Cleared May 06, 2003
IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
K022062
Impact Instrumentation, Inc.
Anesthesiology · 315d
Cleared Oct 30, 2002
TRI-PLEX ADAPTER
K010401
The Medical Device Group, Inc.
Anesthesiology · 625d
Cleared Nov 06, 2001
BERNOULLI VENTILATOR MANAGEMENT SYSTEM
K011861
Cardiopulmonary Corp.
Anesthesiology · 145d
Cleared Dec 16, 1996
VENTNET
K963633
Puritan Bennett Corp.
Anesthesiology · 96d
Cleared Mar 07, 1995
NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR
K940739
Newport Medical Instruments, Inc.
Anesthesiology · 383d

About Product Code MOD - Regulatory Context

510(k) Submission Activity

16 total 510(k) submissions under product code MOD since 1995, with 16 receiving FDA clearance (average review time: 253 days).

Submission volume has increased in recent years - 4 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 197 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 →