Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
NHT · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
144 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192871 | B. anthracis Real-time PCR Assay | Centers for Disease Control and Prevention | 2019-11-07 | 30 | 0 |
| K140426 | ANTHRACIS REAL-TIME PCR ASSAY | Centers For Disease Control and Prevention (CDC) | 2014-05-22 | 92 | 0 |
| K131930 | JBAIDS ANTHRAX DETECTION KIT | Biofire Diagnostics, Inc. | 2013-08-05 | 39 | 1 |
| K072631 | JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 | Idaho Technology, Inc. | 2007-12-20 | 93 | 0 |
| K071188 | MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM | Idaho Technology, Inc. | 2007-05-21 | 21 | 0 |
| K051713 | JBAIDS ANTHRAC DETECTION SYSTEM | Idaho Technology, Inc. | 2005-11-18 | 144 | 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