Airway, Esophageal (Obturator)
The Esophageal Obturator Airway is an anesthesiology device inserted into the esophagus to block regurgitation of gastric contents while a separate port delivers oxygen to the lungs, used in emergency airway management when tracheal intubation is not feasible. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CAO, regulated under 21 CFR 868.5650, within the Anesthesiology medical specialty. This device is designated as life-sustaining or life-supporting given its use in emergency airway management.
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Basic Information
- Product Code
- CAO
- Device Class
- FDA class 2
- Regulation Number
- 868.5650
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K971348 | FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM | Feb 27, 1998 | Substantially Equivalent | Green Field Medical Sourcing, Inc. |
| K894032 | EVAC-TUBE | Aug 31, 1989 | Substantially Equivalent | Sharn, Inc. |
| K875226 | ESOPHAGEAL OBTURATOR/TRACHEAL TUBE | Jan 19, 1988 | Substantially Equivalent | Sheridan Catheter Corp. |
| K864200 | VETA/VENTED ESOPHAGEAL TUBE AIRWAY | Mar 17, 1987 | Substantially Equivalent | Cranco Co. |
| K863172 | RESPIRONICS PTL REVIVEEASY | Nov 04, 1986 | Substantially Equivalent | Respironics, Inc. |
| K761195 | ESOPHAGEAL OBTURATION AIRWAY | Dec 09, 1976 | Substantially Equivalent | Mckesson Corp. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.