510(k) · Cleared

Cleared

T2Bacteria Panel

K172708510(k) TraditionalCleared May 24, 2018258-day reviewClass II21 CFR 866.3960

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

T2biosystems, Inc. · QBX Direct Blood Bacterial Nucleic Acid Detection System

Cleared on May 24, 2018 as substantially equivalent to DEN140019 (T2biosystems, Inc., 2014) after a 258-day review. Its family tree reaches back 1 generation to 2014. 1 later device descends from it.

Decided: May 24, 2018
Review: 258 days
Class: Class II
Product code: QBX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN140019 (2014). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN140019 T2CANDIDA and T2DX InstrumentT2biosystems, Inc. · 2014
This deviceK172708 T2Bacteria PanelT2biosystems, Inc. · 2018
Descendant · cites it directly · 0 of its ownK233184 T2Bacteria® PanelT2biosystems, Inc. · 2024

Most influential descendants

Showing 1 of 1 · See all

K233184T2Bacteria® PanelT2biosystems, Inc. · 2024 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN140019	T2CANDIDA and T2DX Instrument	T2biosystems, Inc.	2014	—
0 (this device)	K172708	T2Bacteria Panel	T2biosystems, Inc.	2018	—
+1	K233184	T2Bacteria® Panel	T2biosystems, Inc.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2024	1	0

FIG. 1 — Lineage of K172708, 2014–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QBX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QBX device

#1 K233184 T2Bacteria® Panelscore 7.1 · 2 generations · no Class I recall

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	DEN140019	T2CANDIDA and T2DX Instrument Summary page 5 …tial Equivalence COMPARISON OF NEW DEVICE WITH PREDICATE DEVICE T2Bacteria Panel T2Candida Panel (DN 140019) Characteristic (New Device) (Primary Predicate Device)…	T2biosystems, Inc.	2014	—

Also cleared against DEN140019: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K233184	T2Bacteria® Panel	T2biosystems, Inc.	2024	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K233184 (T2biosystems, Inc., 2024) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate DEN140019.

How does its category compare?

All QBX devices

QBX Direct Blood Bacterial Nucleic Acid Detection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · QBX

1in 2024

2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QBX

Too few QBX 510(k)s in any year since 2007 to give a median.

Recalls per year · QBX

No recall names QBX since 2007.

Adverse event reports per year · QBX

31in 2024

2007high 31 (2024) · low 0 (2007)2025

MAUDE reports naming product code QBX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	7
2023	0	—	17
2024	1	—	31
2025	0	—	0
2026	0	—	—

What is it indicated for?

The T2Bacteria Panel run on the T2Dx Instrument is a qualitative T2 magnetic resonance (T2MR) test for the direct detection of bacterial species in K2EDTA human whole blood specimens from patients with suspected bacteremia. The T2Bacteria Panel identifies five species of bacteria: Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus. The T2Bacteria Panel is indicated as an aid in the diagnosis…

Read the full statement (130 words)

The T2Bacteria Panel is indicated as an aid in the diagnosis of bacteremia and results should be used in conjunction with other clinical and laboratory data. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification, and for organisms not detected by the T2Bacteria Panel.

Results from the T2Bacteria Panel are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions in patients with suspected bacteremia.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K172708 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172708: T2Bacteria Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172708

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026