Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5895](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5895) → MOD — Accessory To Continuous Ventilator (Respirator)

# MOD · Accessory To Continuous Ventilator (Respirator)

_Anesthesiology · 21 CFR 868.5895 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD

## Overview

- **Product Code:** MOD
- **Device Name:** Accessory To Continuous Ventilator (Respirator)
- **Regulation:** [21 CFR 868.5895](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5895)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **3rd-party reviewable:** yes

## Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K242485](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K242485.md) | EveryWare | Breas Medical AB | May 20, 2025 | SESE |
| [K161411](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K161411.md) | Care Cycle Connect Application | Respironics, Inc. | Feb 17, 2017 | SESE |
| [K091461](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K091461.md) | BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE | Cardiopulmonary Corp. | Aug 14, 2009 | SESE |
| [K052751](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K052751.md) | VENTLINK SYSTEM | Mediserve Information Systems, Inc. | Dec 23, 2005 | SESE |
| [K052244](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K052244.md) | IISIS, VERSION 1.0 | Innovision Medical Technologies, LLC | Oct 13, 2005 | SESE |
| [K040712](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K040712.md) | AIR SAFETY HEPA, MODEL 3500 | Air Safety, Ltd. | Jun 3, 2004 | SESE |
| [K022062](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K022062.md) | IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 | Impact Instrumentation, Inc. | May 6, 2003 | SESE |
| [K010401](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K010401.md) | TRI-PLEX ADAPTER | The Medical Device Group, Inc. | Oct 30, 2002 | SESE |
| [K011861](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K011861.md) | BERNOULLI VENTILATOR MANAGEMENT SYSTEM | Cardiopulmonary Corp. | Nov 6, 2001 | SESE |
| [K963633](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K963633.md) | VENTNET; CENTRAL MONITORING STATION | Puritan Bennett Corp. | Dec 16, 1996 | SESE |
| [K935788](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K935788.md) | BICORE SMARTCATH INTRATRACHEAL CATHETER | Bicore Monitoring Systems | Jul 3, 1995 | SESE |
| [K936156](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K936156.md) | VENTILATION MECHANICS MONITOR MODEL VMM-100 | Smith Industries Medical Systems (Sims) | Jun 27, 1995 | SESE |
| [K940739](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K940739.md) | NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR | Newport Medical Instruments, Inc. | Mar 7, 1995 | SESE |

## Top Applicants

- Cardiopulmonary Corp. — 2 clearances
- Air Safety, Ltd. — 1 clearance
- Bicore Monitoring Systems — 1 clearance
- Breas Medical AB — 1 clearance
- Impact Instrumentation, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD)

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