Product Code: MOD FDA class 2 21 CFR 868.5895

Accessory To Continuous Ventilator (Respirator)

Anesthesiology

Accessories to Continuous Ventilators (Respirators) are supplementary components used in conjunction with continuous ventilators to support their operation, such as breathing circuits, filters, humidifiers, and connectors. Classified as FDA Class 2 under 21 CFR 868.5895 in the Anesthesiology specialty, these accessories require 510(k) premarket notification. The product code is MOD, and these accessories are eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MOD
Device Class: FDA class 2
Regulation Number: 868.5895
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 14 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260051	CorVision® (91-205-Z0014)	May 12, 2026	Substantially Equivalent	CorVent® Medical, Inc.
K242485	EveryWare	May 20, 2025	Substantially Equivalent	Breas Medical AB
K161411	Care Cycle Connect Application	Feb 17, 2017	Substantially Equivalent	Respironics, Inc.
K091461	BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE	Aug 14, 2009	Substantially Equivalent	Cardiopulmonary Corp.
K052751	VENTLINK SYSTEM	Dec 23, 2005	Substantially Equivalent	Mediserve Information Systems, Inc.
K052244	IISIS, VERSION 1.0	Oct 13, 2005	Substantially Equivalent	Innovision Medical Technologies, LLC
K040712	AIR SAFETY HEPA, MODEL 3500	Jun 03, 2004	Substantially Equivalent	Air Safety, Ltd.
K022062	IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00	May 06, 2003	Substantially Equivalent	Impact Instrumentation, Inc.
K010401	TRI-PLEX ADAPTER	Oct 30, 2002	Substantially Equivalent	The Medical Device Group, Inc.
K011861	BERNOULLI VENTILATOR MANAGEMENT SYSTEM	Nov 06, 2001	Substantially Equivalent	Cardiopulmonary Corp.
K963633	VENTNET; CENTRAL MONITORING STATION	Dec 16, 1996	Substantially Equivalent	Puritan Bennett Corp.
K935788	BICORE SMARTCATH INTRATRACHEAL CATHETER	Jul 03, 1995	Substantially Equivalent	Bicore Monitoring Systems
K936156	VENTILATION MECHANICS MONITOR MODEL VMM-100	Jun 27, 1995	Substantially Equivalent	Smith Industries Medical Systems (Sims)
K940739	NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR	Mar 07, 1995	Substantially Equivalent	Newport Medical Instruments, Inc.