Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bayer Healthcare, LLC — Predicate Candidate Screening
46 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
261 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171802 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) | Bayer Healthcare, LLC | 2018-03-07 | 261 | 0 |
| K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) | Bayer Healthcare, LLC | 2015-12-22 | 84 | 0 |
| K130265 | CONTOUR NEXT EZ BLOOD GLUCOSE METER | Bayer Healthcare, LLC | 2014-06-23 | 504 | 0 |
| K121190 | CONTOUR NEXT BLOOD GLUCOSE METER | Bayer Healthcare, LLC | 2012-07-26 | 98 | 0 |
| K110587 | CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST | Bayer Healthcare, LLC | 2012-03-28 | 393 | 0 |
| K093930 | DIDGET WORLD REPORTS | Bayer Healthcare, LLC | 2010-03-12 | 80 | 0 |
| K090628 | DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOS | Bayer Healthcare, LLC | 2009-12-04 | 270 | 0 |
| K090413 | A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+( | Bayer Healthcare, LLC | 2009-05-14 | 85 | 2 |
| K082486 | GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE | Bayer Healthcare, LLC | 2008-10-08 | 41 | 0 |
| K063845 | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 | Bayer Healthcare, LLC | 2007-12-07 | 345 | 0 |
| K063276 | CLINITEK ADVANTUS, MODEL 1420 | Bayer Healthcare, LLC | 2006-12-28 | 59 | 0 |
| K062347 | ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM | Bayer Healthcare, LLC | 2006-11-22 | 104 | 0 |
| K061137 | ADVIA IMS CPSA CONTROL | Bayer Healthcare, LLC | 2006-07-06 | 73 | 0 |
| K061139 | BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATOR | Bayer Healthcare, LLC | 2006-07-06 | 73 | 0 |
| K053020 | TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM | Bayer Healthcare, LLC | 2005-12-30 | 65 | 3 |
| K052503 | TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYST | Bayer Healthcare, LLC | 2005-12-14 | 92 | 0 |
| K051693 | MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AU | Bayer Healthcare, LLC | 2005-12-07 | 167 | 0 |
| K052163 | ADVIA IMS GLUCOSE ASSAY | Bayer Healthcare, LLC | 2005-10-11 | 63 | 0 |
| K052242 | ADVIA CHEMISTRY MICROALBUMIN CONTROLS | Bayer Healthcare, LLC | 2005-10-03 | 47 | 0 |
| K051619 | LIPOPROTEIN FOR MULTIPLE ANALYTES | Bayer Healthcare, LLC | 2005-08-01 | 45 | 0 |
| K050374 | ADVIA IMS LITHIUM ASSAY | Bayer Healthcare, LLC | 2005-06-15 | 121 | 3 |
| K051265 | ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE | Bayer Healthcare, LLC | 2005-06-13 | 28 | 0 |
| K050632 | ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY | Bayer Healthcare, LLC | 2005-05-26 | 78 | 0 |
| K043228 | ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) A | Bayer Healthcare, LLC | 2005-04-22 | 151 | 0 |
| K042807 | ADVIA IMS VALPROIC ACID METHOD | Bayer Healthcare, LLC | 2005-02-08 | 119 | 0 |
| K042808 | ADVIA IMS CARBAMAZEPINE METHOD | Bayer Healthcare, LLC | 2005-02-08 | 119 | 0 |
| K043158 | ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM | Bayer Healthcare, LLC | 2004-12-22 | 37 | 0 |
| K043311 | ASCENSIA ELITE DIABETES CARE SYSTEM | Bayer Healthcare, LLC | 2004-12-22 | 21 | 0 |
| K042251 | BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM | Bayer Healthcare, LLC | 2004-09-17 | 28 | 0 |
| K041133 | MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCE | Bayer Healthcare, LLC | 2004-07-02 | 63 | 7 |
| K040425 | ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) A | Bayer Healthcare, LLC | 2004-06-14 | 117 | 0 |
| K033791 | BAYER SPECIFIC PROTEIN REFERENCE SERUM | Bayer Healthcare, LLC | 2004-02-13 | 71 | 0 |
| K032563 | CLINITEST HCG PREGNANCY TEST | Bayer Healthcare, LLC | 2003-12-23 | 125 | 2 |
| K031947 | BAYER CLINITEK STATUS ANALYZER | Bayer Healthcare, LLC | 2003-12-19 | 178 | 0 |
| K031560 | BAYER RAPIDLAB 1200 SYSTEM | Bayer Healthcare, LLC | 2003-12-17 | 212 | 9 |
| K032525 | BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER | Bayer Healthcare, LLC | 2003-09-09 | 25 | 0 |
| K032524 | ADVIA 60 HEMATOLOGY ANALYZER | Bayer Healthcare, LLC | 2003-09-08 | 24 | 0 |
| K031683 | TOX AMMONIA CALIBRATOR | Bayer Healthcare, LLC | 2003-08-06 | 68 | 1 |
| K031644 | BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL | Bayer Healthcare, LLC | 2003-06-25 | 29 | 0 |
| K031682 | LIPOPROTEIN CALIBRATOR | Bayer Healthcare, LLC | 2003-06-25 | 26 | 0 |
| K031393 | BAYER ADVIA CENTAUR CA 19-9 ASSAY | Bayer Healthcare, LLC | 2003-06-24 | 53 | 6 |
| K031038 | ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY | Bayer Healthcare, LLC | 2003-06-23 | 83 | 5 |
| K030804 | BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR | Bayer Healthcare, LLC | 2003-04-10 | 28 | 0 |
| K030801 | BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL | Bayer Healthcare, LLC | 2003-04-09 | 27 | 0 |
| K030169 | SETPOINT CHEMISTRY CALIBRATOR | Bayer Healthcare, LLC | 2003-01-31 | 14 | 0 |
| K030102 | ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 | Bayer Healthcare, LLC | 2003-01-24 | 14 | 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