BYF · Mask, Oxygen, Low Concentration, Venturi
Anesthesiology · 21 CFR 868.5600 · Class 1
Overview
| Product Code | BYF |
|---|---|
| Device Name | Mask, Oxygen, Low Concentration, Venturi |
| Regulation | 21 CFR 868.5600 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Cleared Devices (19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K955483 | TRACH MASK MODEL (245, 246) | Hospitak, Inc. | Feb 28, 1996 | SESE |
| K951652 | VENTIMASK MK IV | Flexicare Medical, Ltd. | Apr 27, 1995 | SESE |
| K894457 | CARNATION TRACHEOSTOMY MASKS | Dadsun Corp., Ltd. | Oct 13, 1989 | SESE |
| K860873 | VENTURI MASK/ADULT & PAEDIATRIC | Dhd Medical Products Div. Diemolding Corp. | Mar 20, 1986 | SESE |
| K860874 | VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC | Dhd Medical Products Div. Diemolding Corp. | Mar 19, 1986 | SESE |
| K852618 | OXY-DIAL | Ashai Co. , Ltd. | Sep 18, 1985 | SESE |
| K832725 | DUAL DIAL VENTURI STYLE MASK | Airlife, Inc. | Sep 20, 1983 | SESE |
| K812066 | PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN | Airlife, Inc. | Aug 3, 1981 | SESE |
| K810947 | AIR ENTRAINMENT TRACH T | Airlife, Inc. | Jun 2, 1981 | SESE |
| K810946 | ADULT & PEDIATRIC TRACHEOSTOMY MASKS | Airlife, Inc. | Jun 2, 1981 | SESE |
| K810373 | VENTURI MASK/DELIVERY SYSTEM #'S | Todd Industries, Inc. | Mar 17, 1981 | SESE |
| K810430 | VENTURI MASK/DELIVERY SYSTEM #6078 | Todd Industries, Inc. | Mar 13, 1981 | SESE |
| K790146 | MASK, PERCENTO | Airlife, Inc. | Feb 6, 1979 | SESE |
| K781325 | MARKII VENTIMASKS | Vickers America Medical Corp. | Sep 27, 1978 | SESE |
| K780626 | VENTURI OXYGEN MASK | Hospitak, Inc. | May 26, 1978 | SESE |
| K780011 | CONCHAPAK OXYGEN DILUTER | Respiratory Care, Inc. | Feb 2, 1978 | SESE |
| K772127 | OXYGEN MASK, AIR-ENTRAINMENT | Salter Labs | Jan 3, 1978 | SESE |
| K771385 | 2 JET SET | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 4, 1977 | SESE |
| K760518 | ADAPTER, PER-CEN-TOX-BODY | Landmark Plastics | Sep 3, 1976 | SESE |
Top Applicants
- Airlife, Inc. — 5 clearances
- Todd Industries, Inc. — 2 clearances
- Hospitak, Inc. — 2 clearances
- Dhd Medical Products Div. Diemolding Corp. — 2 clearances
- Vickers America Medical Corp. — 1 clearance
