510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172708Substantially Equivalent

T2Bacteria Panel

T2biosystems, Inc., Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172708 is the FDA 510(k) clearance record for T2Bacteria Panel, a class II device, cleared for T2biosystems, Inc. on under FDA product code QBX (Direct Blood Bacterial Nucleic Acid Detection System). FDA's definition for product code QBX reads: "Amplification, detection and identification of microbial pathogens directly from whole blood specimens". FDA records list 6 510(k) clearances for T2biosystems, Inc., from to . As of , FDA records show no recalls naming K172708.

Clearance record

Decision date
Received
(258 days to decision)
Product code
QBX Direct Blood Bacterial Nucleic Acid Detection System
Regulation
21 CFR 866.3960
Device class
Class II
Review panel
Microbiology
Applicant
T2biosystems, Inc. 101 Hartwell Ave., Lexington MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QBX

Trailing 12 months

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

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