# T2biosystems, Inc.

- Location (FDA's records): Lexington, MA
- FDA decisions: 6 (2014–2024): 5 510(k) clearances and 1 De Novo grant
- Product codes: PII (3), QBX (2), QVR (1)
- Predicates its devices cite: 5 (4 its own); citations of its devices by later devices: 4 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biofire Defense, LLC: 1 (https://510kreport.com/company/biofire-defense)

## Its most-cited devices
- DEN140019: T2CANDIDA and T2DX Instrument (2014), cited by 2
- K172708: T2Bacteria Panel (2018), cited by 1
- K173536: T2Candida 1.1 Panel (2017), cited by 1

## Recent decisions
- K234063: T2Candida 1.1 Panel (Sep 13, 2024)
- K233184: T2Bacteria® Panel (Feb 8, 2024)
- K231336: T2 Biothreat Panel (Sep 15, 2023)
- K172708: T2Bacteria Panel (May 24, 2018)
- K173536: T2Candida 1.1 Panel (Dec 12, 2017)
- DEN140019: T2CANDIDA and T2DX Instrument (Sep 22, 2014)

Source page: https://510kreport.com/company/t2biosystems