Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CEM — Predicate Candidate Screening
89 FDA 510(k) clearances under this product code; the 50 most recent screened below.
66 daysmedian FDA review time
195 days90th percentile
89clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE ind | Roche Diagnostics | 2026-02-12 | 111 | 0 |
| K241037 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2025-01-14 | 273 | 0 |
| K220396 | EasyStat 300 | Medica Corporation | 2023-09-26 | 592 | 0 |
| K230890 | ISE Electrodes | Randox Laboratories, Ltd. | 2023-09-08 | 161 | 0 |
| K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | Diamond Diagnostics, Inc. | 2020-10-01 | 212 | 0 |
| K121012 | FLEXLAB 3.6, ACCELERATOR A3600 | Inpeco S.P.A. | 2012-08-31 | 150 | 10 |
| K121040 | SMARTLYTE ELECTROLYTE ANALYZER | Diamond Diagnostics, Inc. | 2012-08-30 | 147 | 0 |
| K112995 | GEM PREMIER 4000 | Instrumentation Laboratory CO | 2012-05-03 | 209 | 0 |
| K110520 | BIOLIS 12I | Tokyo Boeki Medisys, Inc. | 2012-03-23 | 394 | 0 |
| K112412 | AU5800(R) CHEMISTRY ANALYZER | Beckman Coulter, Inc. | 2011-12-23 | 123 | 7 |
| K112408 | POLY-CHEM 90 ISE MODULE | Polymedco, Inc. | 2011-11-04 | 74 | 0 |
| K112788 | EASTLYTE NA/K/CA/PH | Medica Corp. | 2011-10-20 | 24 | 0 |
| K092686 | ABL90 FLEX SERIES | Radiometer Medical Aps | 2010-08-06 | 338 | 5 |
| K092849 | BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLO | Epocal, Inc. | 2010-03-30 | 195 | 0 |
| K093318 | ACCELERATOR APS | Abbott Laboratories | 2010-02-19 | 119 | 1 |
| K083680 | VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PROD | Ortho-Clinical Diagnostics, Inc. | 2009-02-27 | 77 | 1 |
| K073157 | VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 | Ortho-Clinical Diagnostics, Inc. | 2007-12-07 | 29 | 0 |
| K061107 | DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 | Thermo Electron OY | 2006-08-08 | 110 | 0 |
| K061730 | OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 | Osmetech, Inc. | 2006-08-04 | 45 | 0 |
| K052914 | RX IMOLA | Randox Laboratories, Ltd. | 2006-03-31 | 168 | 1 |
| K060373 | COBAS 6000 SERIES SYSTEM | Roche Diagnostics | 2006-03-13 | 28 | 5 |
| K042291 | UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS | Beckman Coulter, Inc. | 2004-11-12 | 80 | 34 |
| K040750 | BIO-CHEM ANALYZER, MODEL 100 | Clinical Analysis Corporation, Inc. | 2004-10-28 | 219 | 0 |
| K042270 | STAT K IN VITRO DIAGNOSTIC TEST SYSTEM | Stat Chem, Inc. | 2004-10-06 | 44 | 0 |
| K032311 | ROCHE DIAGNOSTICS OMNI S ANALYZER | Roche Diagnostics Corp. | 2003-10-17 | 81 | 8 |
| K013373 | OMNI C ANALYZER | Roche Diagnostics Corp. | 2001-11-02 | 22 | 1 |
| K010061 | DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND | Dade Behring, Inc. | 2001-03-14 | 65 | 0 |
| K993083 | ALCYON 300I (WITH ISE MODULE) ANALYZER | Abbott Laboratories | 1999-10-05 | 20 | 0 |
| K974784 | AVL OPTI CRITICAL CARE ANALYZER | Avl Scientific Corp. | 1998-02-24 | 64 | 0 |
| K970330 | DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE | Dade Intl., Inc. | 1997-04-14 | 76 | 1 |
| K961326 | EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER | Medica Corp. | 1996-06-21 | 74 | 0 |
| K961115 | EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-07 | 48 | 0 |
| K932044 | DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD | Dupont Medical Products | 1993-07-27 | 91 | 0 |
| K922943 | NOVA NA/K/CL/LI MODULE | Nova Biomedical Corp. | 1992-10-13 | 117 | 0 |
| K923038 | MILES POTASSIUM METHOD | Heraeus Kulzer, Inc. | 1992-08-24 | 66 | 0 |
| K915345 | STAT K SYSTEM | Portable Diagnostic Services, Inc. | 1992-07-16 | 233 | 0 |
| K915178 | NOVA 11 NA/K/LI ANALYZER | Nova Biomedical Corp. | 1992-01-27 | 73 | 0 |
| K915177 | NOVA 5 NA/K/C1 ALALYZER | Nova Biomedical Corp. | 1992-01-27 | 73 | 0 |
| K912649 | ISE/K+ | Boehringer Mannheim Corp. | 1991-07-15 | 28 | 0 |
| K900788 | MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER | Datachem, Inc. | 1990-07-05 | 135 | 0 |
| K901039 | IONOMETER EH | Fresenius USA, Inc. | 1990-06-28 | 114 | 0 |
| K901041 | IONOMETER EH-HK AND ACCESSORIES | Fresenius USA, Inc. | 1990-06-18 | 104 | 0 |
| K900300 | LYTENING 2Z LYTENING SYSTEM 31 | Baxter Healthcare Corp | 1990-03-01 | 38 | 0 |
| K897110 | SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM | Medisense, Inc. | 1990-02-27 | 63 | 0 |
| K896692 | AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER | Baxter Healthcare Corp | 1990-01-02 | 35 | 0 |
| K895664 | TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD | Technicon Instruments Corp. | 1989-11-14 | 55 | 0 |
| K890792 | POTASSIUM AND SODIUM ELECTROLYTE ANALYZER | Ionetics, Inc. | 1989-05-03 | 75 | 0 |
| K884769 | MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY | Ciba Corning Diagnostics Corp. | 1989-01-17 | 64 | 0 |
| K884566 | VISION LYTE (TM) POTASSIUM | Abbott Laboratories | 1988-12-02 | 31 | 0 |
| K883240 | AVL MODEL 986 ELECTROLYTE ANALYZER | Avl Scientific Corp. | 1988-09-22 | 52 | 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