Atlas FDA

CAO

6 FDA 510(k) clearances · Product code

86 daysmedian time to decision
323 days90th percentile
6clearances measured

FDA profile

Official device name
Airway, Esophageal (Obturator)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5650
Medical specialty
Anesthesiology
Flags
Life-sustaining
Adverse events (MAUDE)
1997: 1 · 1999: 1 · 2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM (K971348)Green Field Medical Sourcing, Inc.1998-02-27
EVAC-TUBE (K894032)Sharn, Inc.1989-08-31
ESOPHAGEAL OBTURATOR/TRACHEAL TUBE (K875226)Sheridan Catheter Corp.1988-01-19
VETA/VENTED ESOPHAGEAL TUBE AIRWAY (K864200)Cranco Co.1987-03-17
RESPIRONICS PTL REVIVEEASY (K863172)Respironics, Inc.1986-11-04
ESOPHAGEAL OBTURATION AIRWAY (K761195)Mckesson Corp.1976-12-09

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Every clearance here is in the API, with alerts when new ones post.