FDA product code CAE: Airway, Oropharyngeal, Anesthesiology
CAE is the FDA product code for airway, oropharyngeal, anesthesiology. It is a Class I device, regulated under 21 CFR 868.5110 and reviewed by the Anesthesiology panel. FDA has cleared 57 510(k) submissions under CAE, from 51 different applicants. The average 510(k) review took 88 days (median 49). FDA has posted 76 recalls for CAE devices, 22 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Airway, Oropharyngeal, Anesthesiology |
| Device class | Class I |
| Regulation | 21 CFR 868.5110 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CAE clearance
Top CAE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| King Systems Corp. | 3 | 2004-05-04 |
| Mallinckrodt Medical | 2 | 1997-03-28 |
| Westmark Enterprises, Inc. | 2 | 1987-05-04 |
| Inmed Corp. | 2 | 1985-03-12 |
| Respironics, Inc. | 2 | 1984-07-27 |
46 more applicants have CAE clearances. See the full list in Caduvo.
Most recent CAE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130304 | The Laryngeal Mask Co., Ltd. | LMA FAMILY OF AIRWAYS | 2014-05-30 | 477 |
| K033189 | King Systems Corp. | KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 | 2004-05-04 | 216 |
| K033186 | King Systems Corp. | KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 | 2004-04-14 | 196 |
| K021634 | King Systems Corp. | KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 | 2003-01-09 | 237 |
| K955721 | Mallinckrodt Medical | CUFFED OROPHARYNGEAL AIRWAY (COPA) | 1997-03-28 | 466 |
Recalls for CAE devices
76 product recalls in 26 recall events; 22 initiated in the last five years and 20 still open. Most recent: 2026-07-07.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 4 |
| 2023 | 4 |
| 2024 | 9 |
| 2025 | 2 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code CAE?
CAE is the FDA product code for airway, oropharyngeal, anesthesiology. It is a Class I device, regulated under 21 CFR 868.5110 and reviewed by the Anesthesiology panel.
What device class is CAE?
Class I, regulation 21 CFR 868.5110. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CAE?
Across 57 cleared submissions the average was 88 days from receipt to decision (median 49).
Which companies have the most CAE clearances?
King Systems Corp. (3); Mallinckrodt Medical (2); Westmark Enterprises, Inc. (2); Inmed Corp. (2); Respironics, Inc. (2).
Have CAE devices been recalled?
Yes: 76 product recalls across 26 recall events; the most recent began 2026-07-07.
Next steps
- Run an FDA pathway report with predicate devices for product code CAE
- Run a recall and safety report across every CAE manufacturer
- Watch product code CAE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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