CAE · Airway, Oropharyngeal, Anesthesiology
Anesthesiology · 21 CFR 868.5110 · Class 1
Overview
| Product Code | CAE |
|---|---|
| Device Name | Airway, Oropharyngeal, Anesthesiology |
| Regulation | 21 CFR 868.5110 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.
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.
Recent Cleared Devices (20 of 57)
Showing 20 most recent of 57 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K130304 | LMA FAMILY OF AIRWAYS | The Laryngeal Mask Co., Ltd. | May 30, 2014 | SESE |
| K033189 | KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 | King Systems Corp. | May 4, 2004 | SESE |
| K033186 | KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 | King Systems Corp. | Apr 14, 2004 | SESE |
| K021634 | KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 | King Systems Corp. | Jan 9, 2003 | SESE |
| K955721 | CUFFED OROPHARYNGEAL AIRWAY (COPA) | Mallinckrodt Medical | Mar 28, 1997 | SESE |
| K960240 | RUSCH OPTOSAFE | Rusch Intl. | Apr 19, 1996 | SESE |
| K950613 | KEISEI | Keisei (Usa) Co., Ltd. | Feb 14, 1996 | SESE |
| K953400 | GUEDEL AIRWAY | Mallinckrodt Medical | Oct 24, 1995 | SESE |
| K933760 | STB GUEDEL AIRWAY | Save-T-Breath Distributors C.C. | Mar 23, 1994 | SESE |
| K936134 | BERMAN AIRWAY | Smiths Industries Medical Systems, Inc. | Jan 28, 1994 | SESE |
| K922748 | GUEDEL AIRWAY | Oem Medical Div. | Jul 10, 1992 | SESE |
| K913680 | BERMAN INTUBATING/PHARYNGEAL AIRWAY | Chain Plastics Operations, Inc. | Oct 10, 1991 | SESE |
| K904834 | INTAVENT LARYNGEAL MASK | Intavent Intl. S.A. | Jul 26, 1991 | SESE |
| K891926 | KISS OF LIFE | Anthony Don Michael, M.D. | Aug 21, 1989 | SESE |
| K892123 | GOETTINGER EMERGENCY RESUSCITATION TUBE | Plastic Parts Corp. | Jul 14, 1989 | SESE |
| K891586 | ORAL AIRWAY | Dynarex Corp. | May 11, 1989 | SESE |
| K892053 | RESPAKIT | Protectical Health & Safety , Ltd. | Apr 27, 1989 | SESE |
| K890566 | BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES | Medi-Source, Inc. | Mar 15, 1989 | SESE |
| K883593 | #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY | Ecolab, Inc. | Sep 30, 1988 | SESE |
| K881065 | RESUS-AID | Applied Convergent Technologies, Inc. | Jul 14, 1988 | SESE |
Top Applicants
- King Systems Corp. — 3 clearances
- Inmed Corp. — 2 clearances
- Mallinckrodt Medical — 2 clearances
- Respironics, Inc. — 2 clearances
- Westmark Enterprises, Inc. — 2 clearances
