510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971348Substantially Equivalent

Fasttrach Single-Pass Tracheal/esophageal Airway System

Green Field Medical Sourcing, Inc., Shrewsbury MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971348 is the FDA 510(k) clearance record for FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM, a class II device, cleared for Green Field Medical Sourcing, Inc. on under FDA product code CAO (Airway, Esophageal (Obturator)). FDA records list 5 510(k) clearances for Green Field Medical Sourcing, Inc., from to . As of , FDA records show no recalls naming K971348.

Clearance record

Decision date
Received
(323 days to decision)
Product code
CAO Airway, Esophageal (Obturator)
Regulation
21 CFR 868.5650
Device class
Class II
Review panel
Anesthesiology
Applicant
Green Field Medical Sourcing, Inc. 910 Boston Tpke. Rd., Shrewsbury MA
510(k) summary
Statement
Third party review
No

Clearances, product code CAO

Trailing 12 months

FDA records hold no clearances under product code CAO in the trailing twelve months.

FDA records show no clearances under product code CAO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CAO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260