Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Applied BioCode, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
266 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254139 | BioCode® Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | 2026-05-01 | 130 | 0 |
| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2025-01-10 | 109 | 0 |
| K192485 | BioCode Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | 2019-12-23 | 104 | 0 |
| K190585 | Biocode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2019-06-05 | 91 | 0 |
| K180041 | BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2018-09-28 | 266 | 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