Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CGA — Predicate Candidate Screening
401 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
270 days90th percentile
401clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252488 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2026-05-01 | 266 | 0 |
| K210933 | YSI 2900C Biochemistry Analyzer | Ysi, Inc. | 2024-09-30 | 1281 | 0 |
| K220328 | EasyStat 300 | Medica Corporation | 2024-07-26 | 903 | 0 |
| K223179 | Cholestech LDX ™ System | Alere San Diego, Inc. | 2023-09-20 | 344 | 0 |
| K223755 | i-STAT G cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-09-11 | 270 | 0 |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-07-28 | 228 | 0 |
| K223090 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2023-01-27 | 119 | 0 |
| K203549 | Nova Primary Glucose Analyzer System | Nova Biomedical Corporation | 2022-10-18 | 683 | 0 |
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2021-08-13 | 135 | 0 |
| K200349 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020-03-13 | 30 | 0 |
| K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-02-07 | 406 | 0 |
| K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Ortho-Clinical Diagnostics, Inc. | 2019-04-03 | 30 | 0 |
| K183546 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019-02-16 | 58 | 0 |
| K182781 | PTS Professional Chemistry Kit | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2018-12-21 | 81 | 0 |
| K180340 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018-09-26 | 231 | 0 |
| K163433 | VITROS Chemistry Products GLU Slides | Ortho Clinical Diagnostics | 2017-09-18 | 285 | 0 |
| K163271 | i-Stat Alinity System with i-Stat Glucose test | Abbott Point of Care, Inc. | 2017-04-10 | 140 | 0 |
| K162282 | CardioChek Plus Test System, CardioChek Home Test System | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2016-12-22 | 129 | 0 |
| K160402 | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and T | Instrumentation Laboratory CO | 2016-12-14 | 306 | 0 |
| K161818 | GEM Premier 3000 | Instrumentation Laboratory CO | 2016-09-14 | 75 | 3 |
| K153692 | Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyze | Infrared Laboratory Systems, LLC (Dba Synermed) | 2016-06-24 | 184 | 0 |
| K151639 | ABL80 FLEX and ABL80 FLEX CO-OX | Sendx Medical, Inc. | 2015-12-07 | 172 | 0 |
| K142689 | GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glu | Apex BioTechnology Corp. | 2015-08-06 | 318 | 0 |
| K151530 | CardioChek Plus Test System | Polymer Technology Systems, Inc. | 2015-07-07 | 29 | 0 |
| K143750 | MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glu | Apex BioTechnology Corp. | 2015-05-07 | 127 | 0 |
| K142302 | BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Tes | Polymer Technology Systems, Inc. | 2014-10-02 | 45 | 0 |
| K142336 | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm | Arkray Factory, Inc. | 2014-09-17 | 27 | 0 |
| K133584 | IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM | Eoshealth, Inc. | 2014-09-08 | 291 | 1 |
| K124021 | ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELI | Arkray Factory, Inc. | 2014-06-30 | 550 | 0 |
| K131750 | AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM | Apex BioTechnology Corp. | 2014-03-06 | 265 | 0 |
| K120615 | ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PR | Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen | 2013-05-15 | 441 | 2 |
| K113636 | BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) | Philosys Co., Ltd. | 2013-03-08 | 455 | 0 |
| K121706 | FORA V10 BLOOD GLUCOSE MONITORING SYSTEM | Foracare, Inc. | 2013-01-14 | 220 | 0 |
| K122110 | ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM | ACON Laboratories, Inc. | 2012-11-21 | 127 | 0 |
| K121654 | AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP | I-Sens, Inc. | 2012-09-05 | 92 | 0 |
| K120921 | CLEVER CHOICE | Simple Diagnostics, Inc. | 2012-08-21 | 147 | 0 |
| K120759 | CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD | I-Sens, Inc. | 2012-06-05 | 84 | 0 |
| K113670 | ELEMENT BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | 2012-05-08 | 147 | 0 |
| K103230 | AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTR | Bestgen Biotech Corp. | 2012-04-24 | 540 | 0 |
| K120448 | MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MO | Apex BioTechnology Corp. | 2012-04-06 | 52 | 0 |
| K113547 | GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE | Apex BioTechnology Corp. | 2012-03-28 | 118 | 0 |
| K103116 | AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTE | Bestgen Biotech Corp. | 2012-03-13 | 509 | 0 |
| K113208 | GAL-1A BLOOD GLUCOSE MONITORING SYSTEM | Apex BioTechnology Corp. | 2012-01-26 | 86 | 0 |
| K103278 | ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD | I-Sens, Inc. | 2011-10-28 | 357 | 0 |
| K102316 | GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM | Broadmaster Biotech Corporation | 2011-10-07 | 417 | 0 |
| K111371 | ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM | ACON Laboratories, Inc. | 2011-10-06 | 143 | 0 |
| K111728 | EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MON | Eps Bio Technology Corp. | 2011-09-16 | 88 | 0 |
| K101204 | MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP | Apex BioTechnology Corp. | 2011-08-31 | 488 | 0 |
| K103842 | UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNIC | Beckman Coulter, Inc. | 2011-04-27 | 118 | 3 |
| K101947 | IVD-GE02 | Sphere Medical , Ltd. | 2011-03-16 | 247 | 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