Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Bayer Corp. — Predicate Candidate Screening

96 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

75 daysmedian FDA review time

207 days90th percentile

96clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K024062	ASCENSIA BREEZE BLOOD GLUCOSE METER	Bayer Corp.	2003-03-03	84	0
K023944	BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST	Bayer Corp.	2003-02-11	77	0
K024017	BAYER ADVIA CENTAUR HER-2/NEU ASSAY	Bayer Corp.	2003-01-30	57	0
K024234	ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL	Bayer Corp.	2003-01-23	31	0
K022288	COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAY	Bayer Corp.	2002-12-17	155	0
K023584	ASCENSIA DEX 2 DIABETES CARE SYSTEM	Bayer Corp.	2002-11-20	26	0
K020828	CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM	Bayer Corp.	2002-07-24	132	1
K021428	CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM	Bayer Corp.	2002-07-05	63	0
K020806	ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY	Bayer Corp.	2002-03-27	15	0
K013568	CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	Bayer Corp.	2001-12-21	56	0
K012337	BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM	Bayer Corp.	2001-12-06	135	0
K011963	ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY	Bayer Corp.	2001-11-20	151	0
K013272	ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY	Bayer Corp.	2001-10-25	24	0
K012777	ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS	Bayer Corp.	2001-10-22	63	0
K012340	BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)	Bayer Corp.	2001-10-01	69	0
K012205	GLUCOMETER DEX TEST SENSOR	Bayer Corp.	2001-09-12	58	0
K010755	BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY	Bayer Corp.	2001-08-20	160	0
K010668	BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY	Bayer Corp.	2001-07-05	121	0
K003412	ADVIA CENTAUR RUBELLA IGG ASSAY	Bayer Corp.	2001-04-13	162	0
K010201	BAYER ADVIA IMS SYSTEM	Bayer Corp.	2001-03-29	66	0
K003796	ADVIA 120 HEMATOLOGY	Bayer Corp.	2001-02-05	59	0
K002738	BAYER RAPIDPOINT 400 SYSTEM	Bayer Corp.	2000-12-19	109	6
K002376	ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY	Bayer Corp.	2000-10-26	83	0
K992228	BAYER IMMUNO 1 HER-2/NEU ASSAY	Bayer Corp.	2000-09-29	455	0
K001344	ADVIA IMS	Bayer Corp.	2000-06-26	60	0
K000903	ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM	Bayer Corp.	2000-05-18	58	0
K000921	BAYER ADVIA IMS SYSTEM; 200 + 3	Bayer Corp.	2000-05-18	57	0
K994221	BAYER PSA ASSAY	Bayer Corp.	2000-04-13	120	0
K993867	BAYER ADVIA IMS SYSTEM	Bayer Corp.	2000-04-10	147	0
K992662	8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTE	Bayer Corp.	2000-02-15	190	1
K993711	ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITR	Bayer Corp.	1999-12-16	43	0
K993571	BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENT	Bayer Corp.	1999-12-16	56	0
K993353	TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DI	Bayer Corp.	1999-12-06	62	0
K993309	BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY	Bayer Corp.	1999-12-06	63	0
K992257	NEW MULTIPLES REAGENT STRIPS	Bayer Corp.	1999-11-24	141	0
K991315	MICROALBUSTIX REAGENT STRIPS (OTC)	Bayer Corp.	1999-11-12	207	0
K991907	ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM	Bayer Corp.	1999-11-09	155	0
K992136	BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)	Bayer Corp.	1999-11-09	138	0
K992399	ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM	Bayer Corp.	1999-09-15	58	0
K991817	ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM	Bayer Corp.	1999-07-22	56	0
K990649	GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BL	Bayer Corp.	1999-07-09	130	0
K991576	ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM	Bayer Corp.	1999-06-30	55	0
K991242	GLUCOMETER ELITE TEST STRIPS	Bayer Corp.	1999-06-30	79	0
K990346	BAYER ADVIA 1650 CHEMISTRY SYSTEM	Bayer Corp.	1999-05-21	106	12
K983715	THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (	Bayer Corp.	1999-05-14	205	0
K984006	GLUCOMETER ELITE XL BLOOD GLUCOSE METER	Bayer Corp.	1999-03-18	128	0
K982328	BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)	Bayer Corp.	1999-01-29	211	0
K983345	BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY	Bayer Corp.	1998-12-07	75	0
K982714	BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY	Bayer Corp.	1998-10-22	79	0
K982802	BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM	Bayer Corp.	1998-09-22	43	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