Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CKG · Predicate Candidate Screening
30 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
218 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223867 | IDS ACTH II | Immunodiagnostic Systems Limited | 2023-08-18 | 238 | 0 |
| K111335 | ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL | Tosoh Bioscience, Inc. | 2011-12-01 | 203 | 0 |
| K060585 | ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL A | Roche Diagnostics Corp. | 2006-05-03 | 57 | 0 |
| K050748 | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 | Scantibodies Laboratory, Inc. | 2005-05-20 | 59 | 0 |
| K021032 | ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3 | Scantibodies Laboratory, Inc. | 2002-06-03 | 66 | 0 |
| K002638 | FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT | Future Diagnostics B.V. | 2001-01-17 | 146 | 0 |
| K982608 | SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELIS | Sangui Biotech, Inc. | 1998-08-19 | 23 | 0 |
| K962601 | NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORM | Nichols Institute Diagnostics | 1996-12-24 | 175 | 1 |
| K960491 | MICRO HAEMATOCRIT CENTRIFUGE | Hawksley & Sons , Ltd. | 1996-10-18 | 260 | 0 |
| K960066 | IMMULITE ACTH | Diagnostic Products Corp. | 1996-02-16 | 42 | 0 |
| K940271 | INCSTAR ACTH IRMA | Incstar Corp. | 1994-08-02 | 193 | 0 |
| K926396 | ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT | Nichols Institute | 1993-07-27 | 218 | 0 |
| K915727 | ACTH IRMA KIT II MITSUBISHI YUKA | Mitsubishi Yuka America, Inc. | 1992-03-02 | 73 | 0 |
| K910178 | ACTH IRMA KIT MITSUBISHI YUKA | Science Regulatory Services Intl. | 1991-05-22 | 127 | 0 |
| K900147 | MODIFIED DSL-2300 ACTH RIA | Diagnostic Systems Laboratories, Inc. | 1990-03-01 | 49 | 0 |
| K882741 | ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES | Nichols Institute Diagnostics | 1988-08-30 | 60 | 0 |
| K860311 | ACTHK-PR RIA KIT | Compagnie Oris Industrie, S.A. | 1986-04-07 | 69 | 0 |
| K850053 | BACI 6 -ADRENOCORTICOTROOP HORMONE | Euro-Diagnostics BV | 1985-04-08 | 90 | 0 |
| K850882 | ACTH II BY RADIOIMMUNOASSAY | Immuno Nuclear Corp. | 1985-03-21 | 17 | 0 |
| K844181 | ACTH RIA | Syncor Intl. Corp. | 1984-11-27 | 32 | 0 |
| K842249 | ACTH NORMAL RANGE | Diagnostic Systems Laboratories, Inc. | 1984-08-15 | 70 | 0 |
| K833934 | ADRENOCORTICOTROPIC HORMONE TEST | Clinetics Corp. | 1984-04-04 | 142 | 0 |
| K840018 | DPC ACTH KIT | Diagnostic Products Corp. | 1984-03-23 | 78 | 0 |
| K833849 | ACTH RIA | Syncor Intl. Corp. | 1984-01-30 | 87 | 0 |
| K833471 | ADRENOCOR TICOTROPIC HORMONE RADIOIMM | Nichols Institute Diagnostics | 1984-01-11 | 97 | 0 |
| K831855 | HATCH KIT | Radioassay Systems Laboratories, Inc. | 1983-07-28 | 49 | 0 |
| K831826 | ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY | Damon Corp. | 1983-07-18 | 41 | 0 |
| K830893 | ACTH RIA SYSTEM-DSI 2300 | Diagnostic Systems Laboratories, Inc. | 1983-04-27 | 37 | 0 |
| K822115 | SERAGAN ACTH125 I-RIA KIT | Seragen Diagnostics, Inc. | 1982-10-18 | 91 | 0 |
| K811565 | ACTH RADIOIMMUNOASSAY KIT | Immuno Nuclear Corp. | 1981-06-25 | 21 | 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