Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
R2 Diagnostics, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
256 daysmedian FDA review time
714 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102908 | NOFACT IX | R2 Diagnostics, Inc. | 2011-12-19 | 444 | 0 |
| K102851 | NOFACT VIII | R2 Diagnostics, Inc. | 2011-12-19 | 446 | 0 |
| K090105 | LUPOTEK KCT | R2 Diagnostics, Inc. | 2010-12-30 | 714 | 0 |
| K083878 | LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA | R2 Diagnostics, Inc. | 2010-06-25 | 543 | 0 |
| K082631 | THROMBO TEK PSE, MODEL 90-480 | R2 Diagnostics, Inc. | 2008-12-17 | 98 | 0 |
| K062306 | PLASMACON N, PLASMACON L-1, PLASMACON L-2 | R2 Diagnostics, Inc. | 2007-03-16 | 220 | 0 |
| K050817 | T-TEK | R2 Diagnostics, Inc. | 2005-12-12 | 256 | 0 |
| K042919 | FIBROTEK FIB | R2 Diagnostics, Inc. | 2004-11-29 | 38 | 0 |
| K040296 | PHOSPHOPLASTIN RL | R2 Diagnostics, Inc. | 2004-05-24 | 105 | 0 |
| K033471 | PHOSPHOLIN ES AND CALCIUM CHLORIDE | R2 Diagnostics, Inc. | 2004-02-04 | 93 | 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