Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JIT — Predicate Candidate Screening
245 FDA 510(k) clearances under this product code; the 50 most recent screened below.
41 daysmedian FDA review time
133 days90th percentile
245clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | Ortho Clinical Diagnostics | 2017-05-16 | 25 | 0 |
| K170938 | CalSet IGF-1 | Roche Diagnostics | 2017-04-26 | 27 | 0 |
| K170160 | Abbott ARCHITECT Free T3 | Abbott Laboratories | 2017-02-15 | 28 | 0 |
| K163534 | Lumipulse G FSH-N Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-13 | 28 | 0 |
| K163546 | Lumipulse G Progesterone-N Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-13 | 28 | 0 |
| K163544 | Lumipulse G Prolactin | Fujirebio Diagnostics,Inc. | 2017-01-12 | 27 | 0 |
| K163521 | Lumipulse G LH Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-12 | 28 | 0 |
| K163078 | DC-UIBC-CAL | Sekisui Diagnostics P.E.I., Inc. | 2016-12-08 | 35 | 0 |
| K163053 | Lumipulse G E2-III Calibrators | Fujirebio Diagnostics,Inc. | 2016-12-01 | 30 | 0 |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADV | Siemens Healthcare Diagnostics | 2016-11-17 | 66 | 0 |
| K160113 | ST AIA-PACK hsE2 Calibrator Set | Tosoh Bioscience, Inc. | 2016-02-17 | 29 | 0 |
| K153417 | ST AIA-PACK PROG III Calibrator Set | Tosoh Bioscience, Inc. | 2015-12-18 | 23 | 1 |
| K152526 | Elecsys Progesterone III CalSet | Roche Diagnostics | 2015-10-02 | 29 | 0 |
| K151566 | Abbott ARCHITECT Total T4 Calibrators | Abbott Laboratories | 2015-07-10 | 30 | 0 |
| K142985 | UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unic | Beckman Coulter, Inc. | 2015-02-26 | 133 | 0 |
| K143342 | Elecsys T-Uptake Calset | Roche Diagnostics | 2014-12-19 | 28 | 0 |
| K143144 | ST AIA-PACK PROG II Calibrator Set | Tosoh Bioscience, Inc. | 2014-12-03 | 30 | 0 |
| K142181 | RANDOX ALDOLASE CALIBRATION SERUM | Randox Laboratories Limited | 2014-09-18 | 41 | 0 |
| K142021 | Elecsys Estradiol III CalSet | Roche Diagnostics | 2014-08-12 | 18 | 0 |
| K133751 | DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS | Diamond Diagnostics, Inc. | 2014-08-08 | 242 | 0 |
| K141728 | ACE CALIBRATOR | SENTINEL CH. SpA | 2014-07-28 | 32 | 0 |
| K141374 | BICARBONATE CALIBRATOR | Beckman Coulter Ireland, Inc. | 2014-06-30 | 34 | 0 |
| K140112 | CA 125 II CALSET II | Roche Diagnostics | 2014-06-06 | 142 | 0 |
| K140648 | ST AIA-PACK C-PEPTIDE II CALIBRATOR SET | Tosoh Bioscience, Inc. | 2014-04-10 | 28 | 0 |
| K130603 | PATHFAST CTNL CALIBRATORS | Mitsubishi Chemical Medience Corporation | 2014-03-27 | 385 | 0 |
| K132400 | LP(A) CALIBRATORS, AND LP(A) CONTROLS | Biokit, S.A. | 2013-12-19 | 140 | 0 |
| K130628 | PATHFAST CK-MB-II CALIBRATORS | Mitsubishi Chemical Medience Corporation | 2013-10-04 | 210 | 0 |
| K131556 | DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET | Diazyme Laboratories | 2013-06-26 | 28 | 0 |
| K130698 | DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) | Siemens Healthcare Diagnostics | 2013-04-05 | 22 | 0 |
| K122177 | ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 1 | Elitechgroup | 2013-02-15 | 207 | 0 |
| K121027 | DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH | Diamond Diagnostics, Inc. | 2012-12-20 | 260 | 0 |
| K120591 | DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 | Diamond Diagnostics, Inc. | 2012-04-17 | 49 | 0 |
| K113373 | DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL | Siemens Healthcare Diagnostics, Inc. | 2011-12-30 | 44 | 0 |
| K111952 | ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2011-08-19 | 39 | 1 |
| K111762 | ST AIA-PACK DHEA-S CALIBRATOR SET | Tosoh Bioscience, Inc. | 2011-08-05 | 43 | 0 |
| K111023 | ABBOTT ARCHITECT LH CALIBRATORS | Abbott Laboratories | 2011-06-10 | 58 | 0 |
| K103548 | ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 | Siemens Healthcare Diagnostics, Inc. | 2011-06-02 | 181 | 0 |
| K110169 | DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSIO | Siemens Healthcare Diagnostics | 2011-04-07 | 77 | 0 |
| K103836 | ENZYME II CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2011-02-16 | 48 | 1 |
| K103221 | ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 | Roche Diagnostics | 2010-12-23 | 52 | 0 |
| K103360 | DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL | Siemens Corp. | 2010-12-17 | 31 | 0 |
| K102638 | DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS | Diazyme Laboratories | 2010-11-30 | 77 | 0 |
| K092937 | STA-HYBRID HEP CALIBRATOR | Diagnostica Stago, Inc. | 2010-08-02 | 312 | 0 |
| K093357 | DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMON | Diamond Diagnostics, Inc. | 2010-06-24 | 239 | 0 |
| K100293 | ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 | Siemens Heatlhcare Diagnostics, Inc. | 2010-03-19 | 45 | 0 |
| K092570 | ABX PENTRA TPU CAL, MODEL A11A01898 | HORIBA ABX SAS | 2009-10-16 | 56 | 0 |
| K083462 | DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 | Siemens Healthcare Diagnostics | 2009-02-27 | 95 | 0 |
| K082680 | LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MO | Siemens Healthcare Diagnostics | 2008-10-10 | 25 | 0 |
| K081789 | DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2008-09-10 | 77 | 0 |
| K082141 | ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CON | Biokit, S.A. | 2008-09-03 | 35 | 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