T2biosystems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “T2biosystems, Inc.” (first 2017, latest 2024), plus 1 De Novo decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 133 days. Since 2017 the median was 133 days, against 133 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 27 |
| 2018 | 1 | 258 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 130 |
| 2024 | 2 | 200 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name T2biosystems, Inc. took a median 133 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PII | Candida Species Nucleic Acid Detection System | 3 | 2 |
| QBX | Direct Blood Bacterial Nucleic Acid Detection System | 2 | 2 |
| QVR | Multiplex Nucleic Acid Detection System For Biothreat Agents | 1 | 1 |
Review panels
- Microbiology (6)
Most recent T2biosystems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K234063 | T2Candida 1.1 Panel | PII | 2024-09-13 | 266 |
| K233184 | T2Bacteria® Panel | QBX | 2024-02-08 | 133 |
| K231336 | T2 Biothreat Panel | QVR | 2023-09-15 | 130 |
| K172708 | T2Bacteria Panel | QBX | 2018-05-24 | 258 |
| K173536 | T2Candida 1.1 Panel | PII | 2017-12-12 | 27 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN140019 | De Novo | Candida Species Nucleic Acid Detection System | 2014-09-22 |
Recalls
openFDA lists no recalls under a recalling firm named T2biosystems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under T2biosystems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “T2biosystems, Inc.” (first 2017, latest 2024), plus 1 De Novo decision, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by T2biosystems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name T2biosystems, Inc. is 133 days. Since 2017: 133 days, versus 133 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under T2biosystems, Inc.?
The most frequent FDA product codes under this applicant name are PII (Candida Species Nucleic Acid Detection System, 3); QBX (Direct Blood Bacterial Nucleic Acid Detection System, 2); QVR (Multiplex Nucleic Acid Detection System For Biothreat Agents, 1).
Next steps
- See all 5 T2biosystems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PII, T2biosystems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.