MOD · Accessory To Continuous Ventilator (Respirator)
Anesthesiology · 21 CFR 868.5895 · Class 2
Overview
| Product Code | MOD |
|---|---|
| Device Name | Accessory To Continuous Ventilator (Respirator) |
| Regulation | 21 CFR 868.5895 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 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 | EveryWare | Breas Medical AB | May 20, 2025 | SESE |
| K161411 | Care Cycle Connect Application | Respironics, Inc. | Feb 17, 2017 | SESE |
| K091461 | BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE | Cardiopulmonary Corp. | Aug 14, 2009 | SESE |
| K052751 | VENTLINK SYSTEM | Mediserve Information Systems, Inc. | Dec 23, 2005 | SESE |
| K052244 | IISIS, VERSION 1.0 | Innovision Medical Technologies, LLC | Oct 13, 2005 | SESE |
| K040712 | AIR SAFETY HEPA, MODEL 3500 | Air Safety, Ltd. | Jun 3, 2004 | SESE |
| K022062 | IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 | Impact Instrumentation, Inc. | May 6, 2003 | SESE |
| K010401 | TRI-PLEX ADAPTER | The Medical Device Group, Inc. | Oct 30, 2002 | SESE |
| K011861 | BERNOULLI VENTILATOR MANAGEMENT SYSTEM | Cardiopulmonary Corp. | Nov 6, 2001 | SESE |
| K963633 | VENTNET; CENTRAL MONITORING STATION | Puritan Bennett Corp. | Dec 16, 1996 | SESE |
| K935788 | BICORE SMARTCATH INTRATRACHEAL CATHETER | Bicore Monitoring Systems | Jul 3, 1995 | SESE |
| K936156 | VENTILATION MECHANICS MONITOR MODEL VMM-100 | Smith Industries Medical Systems (Sims) | Jun 27, 1995 | SESE |
| K940739 | 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
