FDA product code CAO: Airway, Esophageal (Obturator)
CAO is the FDA product code for airway, esophageal (obturator). It is a Class II device, regulated under 21 CFR 868.5650 and reviewed by the Anesthesiology panel. FDA has cleared 6 510(k) submissions under CAO, from 6 different applicants. The average 510(k) review took 110 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | Airway, Esophageal (Obturator) |
| Device class | Class II |
| Regulation | 21 CFR 868.5650 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every CAO clearance
Top CAO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Green Field Medical Sourcing, Inc. | 1 | 1998-02-27 |
| Sharn, Inc. | 1 | 1989-08-31 |
| Sheridan Catheter Corp. | 1 | 1988-01-19 |
| Cranco Co. | 1 | 1987-03-17 |
| Respironics, Inc. | 1 | 1986-11-04 |
1 more applicants have CAO clearances. See the full list in Caduvo.
Most recent CAO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971348 | Green Field Medical Sourcing, Inc. | FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM | 1998-02-27 | 323 |
| K894032 | Sharn, Inc. | EVAC-TUBE | 1989-08-31 | 86 |
| K875226 | Sheridan Catheter Corp. | ESOPHAGEAL OBTURATOR/TRACHEAL TUBE | 1988-01-19 | 28 |
| K864200 | Cranco Co. | VETA/VENTED ESOPHAGEAL TUBE AIRWAY | 1987-03-17 | 141 |
| K863172 | Respironics, Inc. | RESPIRONICS PTL REVIVEEASY | 1986-11-04 | 78 |
Recalls for CAO devices
openFDA lists no recalls for product code CAO.
Frequently asked questions
What is FDA product code CAO?
CAO is the FDA product code for airway, esophageal (obturator). It is a Class II device, regulated under 21 CFR 868.5650 and reviewed by the Anesthesiology panel.
What device class is CAO?
Class II, regulation 21 CFR 868.5650. Typical premarket route: 510(k).
How long does a 510(k) take for product code CAO?
Across 6 cleared submissions the average was 110 days from receipt to decision (median 82).
Which companies have the most CAO clearances?
Green Field Medical Sourcing, Inc. (1); Sharn, Inc. (1); Sheridan Catheter Corp. (1); Cranco Co. (1); Respironics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CAO
- Run a recall and safety report across every CAO manufacturer
- Watch product code CAO 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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