De Novo · Granted
GrantedT2CANDIDA and T2DX Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
T2biosystems, Inc. · PII Candida Species Nucleic Acid Detection System
Granted on Sep 22, 2014 as a new device type through De Novo after a 118-day review. 4 later devices descend from it.
- Decided
- Sep 22, 2014
- Review
- 118 days
- Class
- Class II
- Product code
- PII
- Recalls
- None
4 later devices descend from it, 2 citing it directly.
- This deviceDEN140019 T2CANDIDA and T2DX InstrumentT2biosystems, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK172708 T2Bacteria PanelT2biosystems, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK173536 T2Candida 1.1 PanelT2biosystems, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK234063 T2Candida 1.1 PanelT2biosystems, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK233184 T2Bacteria® PanelT2biosystems, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K172708T2Bacteria PanelT2biosystems, Inc. · 2018 · cites it directly1descendant
- K173536T2Candida 1.1 PanelT2biosystems, Inc. · 2017 · cites it directly1descendant
- K234063T2Candida 1.1 PanelT2biosystems, Inc. · 2024 · 2 generations on0descendants
- K233184T2Bacteria® PanelT2biosystems, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN140019 | T2CANDIDA and T2DX Instrument | T2biosystems, Inc. | 2014 | — |
| +1 | K172708 | T2Bacteria Panel | T2biosystems, Inc. | 2018 | — |
| +1 | K173536 | T2Candida 1.1 Panel | T2biosystems, Inc. | 2017 | — |
| +2 | K234063 | T2Candida 1.1 Panel | T2biosystems, Inc. | 2024 | — |
| +2 | K233184 | T2Bacteria® Panel | T2biosystems, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA De Novo 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 PII? 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 PII device
- #1 K234063 T2Candida 1.1 Panelscore 8.3 · 2 generations · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K172708 (T2biosystems, Inc., 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PII devicesPII Candida Species Nucleic Acid Detection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PII
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PII
Too few PII 510(k)s in any year since 2007 to give a median.
Recalls per year · PII
No recall names PII since 2007.
Adverse event reports per year · PII
1in 2022
MAUDE reports naming product code PII, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The T2Candida Panel and T2Dx® Instrument is a qualitative T2 Magnetic Resonance (T2MR®) assay for the direct detection of Candida species in EDTA human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. The T2Candida Panel identifies five species of Candida and categorizes them into the following three species groups: 1. Candida albicans and/or Candida tropicalis, 2.…
Read the full statement (171 words)
The T2Candida Panel and T2Dx® Instrument is a qualitative T2 Magnetic Resonance (T2MR®) assay for the direct detection of Candida species in EDTA human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. The T2Candida Panel identifies five species of Candida and categorizes them into the following three species groups:
1. Candida albicans and/or Candida tropicalis,
2. Candida parapsilosis
3. Candida glabrata and/or Candida krusei
The T2Candida Panel does not distinguish between C. albicans and C. tropicalis. The T2Candida Panel does not distinguish between C. glabrata and C. krusei.
The T2Candida Panel is indicated for the presumptive diagnosis of candidemia. The T2Candida Panel is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification.
The T2Candida positive and negative External Controls are intended to be used as quality control samples with the T2Candida Panel when run on the T2Dx® instrument system. These controls are not intended for use with other assays or systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN140019 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN140019: T2CANDIDA and T2DX Instrument.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN140019
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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