510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K882891Substantially Equivalent

A.c.i. Trach Tie

Auxiliary Care, Inc., Coral Gables FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882891 is the FDA 510(k) clearance record for A.C.I. TRACH TIE, a class I device, cleared for Auxiliary Care, Inc. on under FDA product code CBH (Device, Fixation, Tracheal Tube). FDA records list one 510(k) clearance for Auxiliary Care, Inc. As of , FDA records show no recalls naming K882891.

Clearance record

Decision date
Received
(70 days to decision)
Product code
CBH Device, Fixation, Tracheal Tube
Regulation
21 CFR 868.5770
Device class
Class I
Review panel
Anesthesiology
Applicant
Auxiliary Care, Inc. P.O. Box 144757, Coral Gables FL
Third party review
No

Clearances, product code CBH

Trailing 12 months

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

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