Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PII · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234063 | T2Candida 1.1 Panel | T2biosystems, Inc. | 2024-09-13 | 266 | 0 |
| K173536 | T2Candida 1.1 Panel | T2biosystems, Inc. | 2017-12-12 | 27 | 0 |
| DEN140019 | T2CANDIDA AND T2DX INSTRUMENT | T2biosystems, Inc. | 2014-09-22 | 118 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda