Product code CAE
- Device name
- Airway, Oropharyngeal, Anesthesiology
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5110
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130304 | LMA FAMILY OF AIRWAYS | The Laryngeal Mask Co., Ltd. | 2014-05-30 |
| K033189 | KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 | King Systems Corp. | 2004-05-04 |
| K033186 | KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 | King Systems Corp. | 2004-04-14 |
| K021634 | KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 | King Systems Corp. | 2003-01-09 |
| K955721 | CUFFED OROPHARYNGEAL AIRWAY (COPA) | Mallinckrodt Medical | 1997-03-28 |
| K960240 | RUSCH OPTOSAFE | Rusch Intl. | 1996-04-19 |
| K950613 | KEISEI | Keisei (Usa) Co., Ltd. | 1996-02-14 |
| K953400 | GUEDEL AIRWAY | Mallinckrodt Medical | 1995-10-24 |
| K933760 | STB GUEDEL AIRWAY | Save-T-Breath Distributors C.C. | 1994-03-23 |
| K936134 | BERMAN AIRWAY | Smiths Industries Medical Systems, Inc. | 1994-01-28 |
| K922748 | GUEDEL AIRWAY | Oem Medical Div. | 1992-07-10 |
| K913680 | BERMAN INTUBATING/PHARYNGEAL AIRWAY | Chain Plastics Operations, Inc. | 1991-10-10 |
| K904834 | INTAVENT LARYNGEAL MASK | Intavent Intl. S.A. | 1991-07-26 |
| K891926 | KISS OF LIFE | Anthony Don Michael, M.D. | 1989-08-21 |
| K892123 | GOETTINGER EMERGENCY RESUSCITATION TUBE | Plastic Parts Corp. | 1989-07-14 |
| K891586 | ORAL AIRWAY | Dynarex Corp. | 1989-05-11 |
| K892053 | RESPAKIT | Protectical Health & Safety , Ltd. | 1989-04-27 |
| K890566 | BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES | Medi-Source, Inc. | 1989-03-15 |
| K883593 | #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY | Ecolab, Inc. | 1988-09-30 |
| K881065 | RESUS-AID | Applied Convergent Technologies, Inc. | 1988-07-14 |
| K880241 | 'HILT-WAY' RESUSCITATOR | Medifield , Ltd. | 1988-03-31 |
| K874412 | THE PROTECTOR | Tri Jon, Inc. | 1988-02-12 |
| K871403 | MODIFIED C.P.R. MICROSHIELD | Westmark Enterprises, Inc. | 1987-05-04 |
| K861482 | RESUSIKIT | Begley Enterprises, Inc. | 1986-06-17 |
| K862199 | MEDTECH C.P.R. MASK | The Medtech Group, Inc. | 1986-06-13 |
| K860949 | DUAL-AID | Vitalograph , Ltd. | 1986-05-06 |
| K861540 | DISPOSABLE BERMAN AND GUEDEL AIRWAYS | Dryden Corp. | 1986-05-02 |
| K861054 | DISPOSABLE RESCUE BREATHING DEVICE | B & F Medical Products, Inc. | 1986-04-09 |
| K860780 | PLASTIC MOUTH BARRIER HCV-E | Westmark Enterprises, Inc. | 1986-04-02 |
| K854029 | RESPIRATORY RESUSCITATION DEVICE | John H. Harrison | 1986-03-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04816415501416 | SINGLE-USE OROPHARYNGEAL AIRWAY 90 mm | ASSOMEDIKA, OOO | 2026-05-27 |
| 04816415501423 | SINGLE-USE OROPHARYNGEAL AIRWAY 110 mm | ASSOMEDIKA, OOO | 2026-05-27 |
| 04816415501409 | SINGLE-USE OROPHARYNGEAL AIRWAY 40 mm | ASSOMEDIKA, OOO | 2026-05-27 |
| 10193489000160 | Medline | MEDLINE INDUSTRIES, INC. | 2023-06-16 |
| 10193489000153 | Medline | MEDLINE INDUSTRIES, INC. | 2023-06-16 |
| 10080196134045 | Medline | MEDLINE INDUSTRIES, INC. | 2023-01-27 |
| 10080196134014 | Medline | MEDLINE INDUSTRIES, INC. | 2023-01-27 |
| 10080196990726 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2021-11-09 |
| 10080196134007 | Medline | MEDLINE INDUSTRIES, INC. | 2021-11-04 |
| 10190752131613 | Vital Signs™ | AIRLIFE | 2020-01-15 |
| 10190752131293 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752145047 | Vital Signs™ | AIRLIFE | 2020-01-15 |
| 10190752145030 | Vital Signs™ | AIRLIFE | 2020-01-15 |
| 10190752145023 | Vital Signs™ | AIRLIFE | 2020-01-15 |
| 10190752145016 | Vital Signs™ | AIRLIFE | 2020-01-15 |
| 10190752145009 | Vital Signs™ | AIRLIFE | 2020-01-15 |
| 10190752144996 | Vital Signs™ | AIRLIFE | 2020-01-15 |
| 10190752144989 | Vital Signs™ | AIRLIFE | 2020-01-15 |
| 10190752144972 | Vital Signs™ | AIRLIFE | 2020-01-15 |
| 10190752144965 | Vital Signs™ | AIRLIFE | 2020-01-15 |
| 10190752144958 | Vital Signs™ | AIRLIFE | 2020-01-15 |
| 10190752144705 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752144699 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752144682 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752144668 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752144651 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752135208 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752131620 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752131347 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10182151000690 | EndoMask Elite® | MERLYN ASSOCIATES, INC. | 2017-05-30 |