Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5110](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5110) → CAE — Airway, Oropharyngeal, Anesthesiology # CAE · Airway, Oropharyngeal, Anesthesiology _Anesthesiology · 21 CFR 868.5110 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE ## Overview - **Product Code:** CAE - **Device Name:** Airway, Oropharyngeal, Anesthesiology - **Regulation:** [21 CFR 868.5110](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5110) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K130304.md) | LMA FAMILY OF AIRWAYS | The Laryngeal Mask Co., Ltd. | May 30, 2014 | SESE | | [K033189](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K033189.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K033186.md) | KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 | King Systems Corp. | Apr 14, 2004 | SESE | | [K021634](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K021634.md) | KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 | King Systems Corp. | Jan 9, 2003 | SESE | | [K955721](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K955721.md) | CUFFED OROPHARYNGEAL AIRWAY (COPA) | Mallinckrodt Medical | Mar 28, 1997 | SESE | | [K960240](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K960240.md) | RUSCH OPTOSAFE | Rusch Intl. | Apr 19, 1996 | SESE | | [K950613](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K950613.md) | KEISEI | Keisei (Usa) Co., Ltd. | Feb 14, 1996 | SESE | | [K953400](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K953400.md) | GUEDEL AIRWAY | Mallinckrodt Medical | Oct 24, 1995 | SESE | | [K933760](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K933760.md) | STB GUEDEL AIRWAY | Save-T-Breath Distributors C.C. | Mar 23, 1994 | SESE | | [K936134](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K936134.md) | BERMAN AIRWAY | Smiths Industries Medical Systems, Inc. | Jan 28, 1994 | SESE | | [K922748](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K922748.md) | GUEDEL AIRWAY | Oem Medical Div. | Jul 10, 1992 | SESE | | [K913680](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K913680.md) | BERMAN INTUBATING/PHARYNGEAL AIRWAY | Chain Plastics Operations, Inc. | Oct 10, 1991 | SESE | | [K904834](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K904834.md) | INTAVENT LARYNGEAL MASK | Intavent Intl. S.A. | Jul 26, 1991 | SESE | | [K891926](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K891926.md) | KISS OF LIFE | Anthony Don Michael, M.D. | Aug 21, 1989 | SESE | | [K892123](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K892123.md) | GOETTINGER EMERGENCY RESUSCITATION TUBE | Plastic Parts Corp. | Jul 14, 1989 | SESE | | [K891586](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K891586.md) | ORAL AIRWAY | Dynarex Corp. | May 11, 1989 | SESE | | [K892053](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K892053.md) | RESPAKIT | Protectical Health & Safety , Ltd. | Apr 27, 1989 | SESE | | [K890566](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K890566.md) | BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES | Medi-Source, Inc. | Mar 15, 1989 | SESE | | [K883593](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K883593.md) | #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY | Ecolab, Inc. | Sep 30, 1988 | SESE | | [K881065](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE/K881065.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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