BYT · Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Anesthesiology · 21 CFR 868.5935 · Class 2
Overview
| Product Code | BYT |
|---|---|
| Device Name | Ventilator, External Body, Negative Pressure, Adult (Cuirass) |
| Regulation | 21 CFR 868.5935 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K082657 | RTX RESPIRATOR | Medivent Limited | Oct 8, 2008 | SESE |
| K072290 | PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS | Dima Italia Srl | May 29, 2008 | SESE |
| K924341 | HAYEK OSCILLATOR(TM) | Respironics, Inc. | Jul 21, 1993 | SESE |
| K910947 | NEV-10 NEGATIVE PRESSURE VENTILATOR | Lifecare Services, Inc. | Jun 3, 1991 | SESE |
| K905530 | PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM | Puritan Bennett Corp. | Mar 1, 1991 | SESE |
| K902764 | EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM | J. H. Emerson Co. | Nov 19, 1990 | SESE |
| K903745 | THE HAYEK OSCILLATOR | Flexco Medical Instruments | Nov 9, 1990 | SESE |
| K902300 | EASY BREATHER MODEL 100 ACCESSORIES | Progressive Productions , Ltd. | Jul 19, 1990 | SESE |
| K895849 | RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM | Respironics, Inc. | Dec 22, 1989 | SESE |
| K894649 | EMERSON 33-CR CHEST RESPIRATOR | Emerson Intl. Co. | Oct 13, 1989 | SESE |
| K893213 | EASY BREATHER MODEL 100 | Progressive Productions , Ltd. | Aug 4, 1989 | SESE |
| K881808 | EMERSON CHEST RESPIRATOR, MODEL 33-CRE | J. H. Emerson Co. | Aug 4, 1988 | SESE |
| K881689 | LINDLEY II RESUSCITATOR | Lindley Resuscitator, Inc. | Jul 8, 1988 | SESE |
| K863300 | Q101 DIAGNOSTIC SPIROMETER | Quinton, Inc. | Nov 13, 1986 | SESE |
| K860692 | PTR MK II VENTILATOR | Bear Medical Systems, Inc. | May 21, 1986 | SESE |
| K840885 | LAKEVILLE BODY VENTILATOR | Edwards Ventilator Co. | Jul 12, 1984 | SESE |
| K841090 | VENTILATOR EXTERNAL BODY NEGATIVE PRESS | Porta-Lung Co. | May 30, 1984 | SESE |
| K832176 | NEGATIVE PRESSURE CHEST RESPIRATOR PUMP | J. H. Emerson Co. | Sep 12, 1983 | SESE |
| K813326 | TROCKI BODY VENTRILATOR | L.T.D. 3 Co. | Dec 22, 1981 | SESE |
| K792673 | CAM-10 CUIRASS SHELL | Lifecare Services, Inc. | Jan 11, 1980 | SESE |
Top Applicants
- J. H. Emerson Co. — 3 clearances
- Lifecare Services, Inc. — 3 clearances
- Progressive Productions , Ltd. — 2 clearances
- Respironics, Inc. — 2 clearances
- Bear Medical Systems, Inc. — 1 clearance
