510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN170045Unknown

Banyan BTI

Banyan Biomarkers, Inc., San Diego CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN170045 is the FDA 510(k) clearance record for Banyan BTI, a class II device, cleared for Banyan Biomarkers, Inc. on under FDA product code QAT (Brain Trauma Assessment Test). FDA's definition for product code QAT reads: "Intended for in vitro diagnostic use as an aid in the evaluation of patients with suspected mild traumatic brain injury (TBI) in conjunction with other clinical information to assist in determining the need for radiologic (e.g., CT, MR)...". FDA records list one 510(k) clearance for Banyan Biomarkers, Inc. As of , FDA records show no recalls naming DEN170045.

Clearance record

Decision date
Received
(170 days to decision)
Product code
QAT Brain Trauma Assessment Test
Regulation
21 CFR 866.5830
Device class
Class II
Review panel
Immunology
Applicant
Banyan Biomarkers, Inc. 16470 W. Bernardo Dr., San Diego CA
Third party review
No

Clearances, product code QAT

Trailing 12 months

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

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