Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LTK — Predicate Candidate Screening
26 FDA 510(k) clearances under this product code; the 50 most recent screened below.
193 daysmedian FDA review time
432 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240479 | Access OV Monitor | Beckman Coulter, Inc. | 2024-05-10 | 80 | 0 |
| K213510 | IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA | Siemens Healthcare Diagnostics Products, Ltd. | 2023-09-08 | 675 | 0 |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | Ortho Clinical Diagnostics | 2022-12-12 | 216 | 0 |
| K200199 | ADVIA Centaur CA 125II | Siemens Healthcare Diagnostics, Inc. | 2020-04-06 | 70 | 0 |
| K143534 | Elecsys CA-125 II assay | Roche Professional Diagnostics | 2015-08-06 | 237 | 0 |
| K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction | Fujirebio Diagnostics,Inc. | 2015-05-21 | 230 | 0 |
| K100321 | DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMEN | Siemens Healthcare Diagnostics | 2011-04-12 | 432 | 0 |
| K080469 | VIDAS CA 15-3 ASSAY | bioMerieux, Inc. | 2009-06-22 | 487 | 0 |
| K080561 | VIDAS CA 125 II ASSAY | bioMerieux, Inc. | 2009-04-10 | 407 | 0 |
| K072794 | IMMULITE 2500 OM-MA, MODEL L5KOP | Siemens Medical Solutions Diagnostics | 2007-11-05 | 35 | 0 |
| K042731 | ARCHITECT CA 125 II ASSAY | Fujirebio Diagnostics,Inc. | 2004-11-19 | 49 | 0 |
| K031297 | ACCESS OV MONITOR ASSAY | Beckman Coulter, Inc. | 2003-05-02 | 8 | 0 |
| K023597 | ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY | Beckman Coulter, Inc. | 2002-12-11 | 44 | 0 |
| K023891 | ST AIA-PACK CA 125 ENZYME IMMUNOASSAY | Tosoh Medics, Inc. | 2002-12-06 | 14 | 0 |
| K022329 | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Bayer Diagnostics Corp. | 2002-11-27 | 132 | 0 |
| K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM | Bayer Corp. | 2002-07-24 | 132 | 1 |
| K990431 | AIA-PACK CA 125 | Tosoh Medics, Inc. | 1999-06-03 | 112 | 0 |
| K983715 | THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( | Bayer Corp. | 1999-05-14 | 205 | 0 |
| K983875 | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITR | Ortho-Clinical Diagnostics, Inc. | 1999-05-14 | 193 | 1 |
| K983391 | IMMULITE 2000 OM-MA MODEL L2KOP2 | Diagnostic Products Corp. | 1998-10-15 | 20 | 1 |
| K981297 | IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 | Diagnostic Products Corp. | 1998-09-18 | 163 | 1 |
| K980240 | ELECSYS CA 125II ON THE ELECSYS 1010 | Boehringer Mannheim Corp. | 1998-03-25 | 61 | 0 |
| K972162 | ELECSYS CA 125 II | Boehringer Mannheim Corp. | 1998-03-18 | 282 | 0 |
| K964185 | IMX CA 125 | Abbott Diagnostics | 1997-11-04 | 379 | 4 |
| K964020 | AXSYM CA 125 | Abbott Laboratories | 1997-11-04 | 393 | 4 |
| K964098 | CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | 1997-10-31 | 385 | 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