Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NHG — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
197 daysmedian FDA review time
587 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150528 | Cortisol Saliva Luminescence Immunoassay | Ibl International GmbH | 2015-11-25 | 268 | 0 |
| K102841 | PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY | Pantex, Div. Bio-Analysis, Inc. | 2012-05-08 | 587 | 0 |
| K070788 | ELECSYS CORTISOL TEST SYSTEM | Roche Diagnostics | 2007-10-05 | 197 | 0 |
| K051733 | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL | Drg Intl., Inc. | 2005-12-07 | 162 | 0 |
| K043175 | ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE | Roche Diagnostics Corp. | 2004-11-24 | 8 | 1 |
| K031348 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY | Salimetrics, LLC | 2003-06-10 | 60 | 0 |
| K011323 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1 | Salimetrics, LLC | 2001-12-17 | 230 | 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