510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183090Substantially Equivalent

Relieva Tract Balloon Dilation System

Acclarent Inc, Irvin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183090 is the FDA 510(k) clearance record for Relieva Tract Balloon Dilation System, a class I device, cleared for Acclarent, Inc. on under FDA product code QGK (Balloon, Nasal Airway). FDA's definition for product code QGK reads: "The nasal airway balloon is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction". FDA records list 45 510(k) clearances for Acclarent, Inc., from to . As of , FDA records show no recalls naming K183090.

Clearance record

Decision date
Received
(164 days to decision)
Product code
QGK Balloon, Nasal Airway
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Acclarent, Inc. 33 Technology Dr., Irvin CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QGK

Trailing 12 months

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

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