510(k) · Cleared
ClearedFasttrach Single-Pass Tracheal/Esophageal Airway System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Green Field Medical Sourcing, Inc. · CAO Airway, Esophageal (Obturator)
Cleared on Feb 27, 1998 after a 323-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 27, 1998
- Review
- 323 days
- Class
- Class II
- Product code
- CAO
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All CAO devicesCAO Airway, Esophageal (Obturator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAO
FDA has decided no CAO device since 2007.
Median 510(k) review, days · CAO
Too few CAO 510(k)s in any year since 2007 to give a median.
Recalls per year · CAO
No recall names CAO since 2007.
Adverse event reports per year · CAO
1in 2021
MAUDE reports naming product code CAO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (136 words)
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971348 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971348: Fasttrach Single-Pass Tracheal/Esophageal Airway System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971348
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026