# K971348: Fasttrach Single-Pass Tracheal/Esophageal Airway System

- Pathway: 510(k) (Traditional)
- Applicant: Green Field Medical Sourcing, Inc.
- Decided: Feb 27, 1998 after 323 days
- Product code: CAO (Airway, Esophageal (Obturator))
- Device class: 2
- Regulation: 21 CFR 868.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
1. To establish a patent airway to provide ventilation to a patient who has undergone cardiac* and/or pulmonary arrest. 2. To establish a protected airway where a compromised or obstructed airway exists in an unconscious patient.* 3. To establish a patent airway in a conscious patient who is unable to ventilate adequately. * 4. To establish a patent airway where a rescuer is unable to ventilate the unconscious patient with conventional methods.* 5. This device is particularly indicated where standard tracheal tube intubation may be difficult or not possible. Where either tracheal or esophageal obturator airway is indicated. Applicable to larger children, small adult or adult depending on sizes of our product available, with applied clinical judgement required. 8. For use by a person trained and experienced in airway management and the use of this device.

Source page: https://510kreport.com/device/K971348
Methodology: https://510kreport.com/methodology