Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JFT — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
127 daysmedian FDA review time
264 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242505 | Elecsys Cortisol III | Roche Diagnostics | 2025-07-17 | 329 | 0 |
| K192788 | ADVIA Centaur Cortisol (COR) | Siemens Healthcare Diagnostics, Inc. | 2019-11-25 | 56 | 0 |
| K152227 | Elecsys Cortisol II, Cortisol II CalSet | Roche Diagnostics | 2016-04-27 | 264 | 0 |
| K142723 | ADVIA Centaur Cortisol (COR) Assy | Siemens Healthcare Diagnostics, Inc. | 2015-03-31 | 189 | 1 |
| K062204 | ARCHITECT CORTISOL ASSAY | Seradyn, Inc. | 2006-09-22 | 52 | 0 |
| K033731 | AXSYM CORTISOL ASSAY | Fujirebio Diagnostics,Inc. | 2004-02-20 | 84 | 0 |
| K021218 | ELECSYS CORTISOL TEST SYSTEM | Roche Diagnostics Corp. | 2002-09-09 | 145 | 0 |
| K962559 | ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1996-11-05 | 127 | 2 |
| K954591 | AIA-PACK CORT ASSAY | Tosoh Medics, Inc. | 1995-12-15 | 74 | 0 |
| K934317 | CIDBA CORNING ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1994-05-13 | 254 | 0 |
| K930732 | DELFIA CORTISOL KIT | Wallac OY | 1993-07-27 | 166 | 0 |
| K931031 | VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT | Biomerieux Vitek, Inc. | 1993-07-27 | 148 | 0 |
| K926322 | ACCESS(R) CORTISOL REAGENTS | Bio-Rad Laboratories, Inc. | 1993-05-26 | 161 | 0 |
| K900010 | NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR | Kallestad Diag, A Div. of Erbamont, Inc. | 1990-04-03 | 91 | 0 |
| K895421 | CORTISOL TEST SYSTEM | Baxter Healthcare Corp | 1989-12-07 | 97 | 0 |
| K893954 | CEDIA CORTISOL ASSAY | Microgenics Corp. | 1989-10-31 | 152 | 0 |
| K863422 | DELFIA(TM) CORTISOL KIT | Lkb Instruments, Inc. | 1986-09-26 | 22 | 0 |
| K854419 | TDX CORTISOL | Abbott Laboratories | 1985-11-25 | 21 | 1 |
| K852927 | TDX CORTISOL | Abbott Laboratories | 1985-08-05 | 27 | 1 |
| K833932 | SYVA ADVANCE CORTISOL ASSAY | Syva Co. | 1983-12-29 | 45 | 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