FDA applicant

T2biosystems, Inc.

Lexington, MA6 decisions2014–20240 recalls

FDA records 6 decisions for T2biosystems, Inc. (Lexington, MA) from 2014 to 2024: 5 510(k) clearances and 1 De Novo grant. Most are in product codes PII (Candida Species Nucleic Acid Detection System) and QBX (Direct Blood Bacterial Nucleic Acid Detection…). Its devices cite 5 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided T2biosystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2014high 2 (2024) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — T2biosystems, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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T2biosystems, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?