510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961707Substantially Equivalent

Trach-Eze Closed Ventilation Suction System

Sorenson Critical Care, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961707 is the FDA 510(k) clearance record for TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM, a class I device, cleared for Sorenson Critical Care on under FDA product code BSY (Catheters, Suction, Tracheobronchial). FDA records list one 510(k) clearance for Sorenson Critical Care. As of , FDA records show one recall naming K961707.

Clearance record

Decision date
Received
(313 days to decision)
Product code
BSY Catheters, Suction, Tracheobronchial
Regulation
21 CFR 868.6810
Device class
Class I
Review panel
Anesthesiology
Applicant
Sorenson Critical Care 79 W. 4500 S., Suite 9, Salt Lake City UT
510(k) summary
Statement
Third party review
No

Clearances, product code BSY

Trailing 12 months

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

FDA records show no clearances under product code BSY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BSY, 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