510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183661Substantially Equivalent

ClearEdge Balance System

Quadrant Biosciences, Syracuse NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183661 is the FDA 510(k) clearance record for ClearEdge Balance System, cleared for Quadrant Biosciences on under FDA product code LXV (Apparatus, Vestibular Analysis). FDA records list one 510(k) clearance for Quadrant Biosciences. As of , FDA records show no recalls naming K183661.

Clearance record

Decision date
Received
(299 days to decision)
Product code
LXV Apparatus, Vestibular Analysis
Device class
Unclassified
Review panel
Unknown
Applicant
Quadrant Biosciences 505 Irving Ave., Syracuse NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LXV

Trailing 12 months

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

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