510(k) · Cleared
ClearedT2Candida 1.1 Panel
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
Cleared on Dec 12, 2017 as substantially equivalent to DEN140019 (T2biosystems, Inc., 2014) after a 27-day review. Its family tree reaches back 1 generation to 2014. 1 later device descends from it.
- Decided
- Dec 12, 2017
- Review
- 27 days
- Class
- Class II
- Product code
- PII
- 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.
Most influential descendants
Showing 1 of 1 · See all- K234063T2Candida 1.1 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) | K173536 | T2Candida 1.1 Panel | T2biosystems, Inc. | 2017 | — |
| +1 | K234063 | T2Candida 1.1 Panel | T2biosystems, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
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 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
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 | Decided |
|---|---|---|---|
| * | DEN140019 | T2CANDIDA and T2DX InstrumentSummary page 5…nciple of operation of the T2Candida 1.1 Panel on the T2Dx instrument is equivalent to that used in the original T2Candida Panel, as submitted and cleared (DEN140019, Summary Decision September, 2014). The T2Candida 1.1 Panel utilizes the same magnetic resonance-based detection (T… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K234063 | T2Candida 1.1 Panel | 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?
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. 2017, 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?
T2Candida 1.1 Panel and T2Dx Instrument is a qualitative T2 Magnetic Resonance (T2MR) assay for the direct detection of Candida species in K2EDTA human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. The T2Candida 1.1 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 (153 words)
T2Candida 1.1 Panel and T2Dx Instrument is a qualitative T2 Magnetic Resonance (T2MR) assay for the direct detection of Candida species in K2EDTA human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. The T2Candida 1.1 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 1.1 Panel is indicated for the presumptive diagnosis of candidemia. The T2Candida 1.1 Panel is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification. The T2Candida QCheck Positive and T2Dx QCheck Negative External Controls are intended to be used as quality control samples with the T2Candida 1.1 Panel when run on the T2Dx Instrument. These controls are not intended for use with other assays or systems.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173536: T2Candida 1.1 Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173536
Report an extraction error
Are you the manufacturer?
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