Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Siemens Healthcare Diagnostics · Predicate Candidate Screening

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

113 daysmedian FDA review time

364 days90th percentile

92clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243570	Dimension LOCI Thyroid Stimulating Hormone Flex reagent cart	Siemens Healthcare Diagnostics	2025-04-25	158	0
K162977	ADVIA 2120i, ADVIA 2120	Siemens Healthcare Diagnostics	2017-08-11	289	0
K162298	LOCI Total Vitamin D Total Assay, LOCI VITD CAL	Siemens Healthcare Diagnostics	2017-03-16	212	0
K161954	Atellica Solution, Atellica A-LYTE Integrated Multisensor Na	Siemens Healthcare Diagnostics	2017-03-09	234	2
K162538	ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADV	Siemens Healthcare Diagnostics	2016-11-17	66	0
K151964	Xprecia Stride Coagulation System, Xprecia System PT Control	Siemens Healthcare Diagnostics	2016-09-30	442	0
K150168	Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimensio	Siemens Healthcare Diagnostics	2015-11-04	282	2
K143720	Dimension Vista MMB Assay	Siemens Healthcare Diagnostics	2015-09-18	263	1
K140790	Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimensi	Siemens Healthcare Diagnostics	2015-06-15	441	1
K150132	IMMULITE IGF Control Module, IMMULITE Gastrin Control Module	Siemens Healthcare Diagnostics	2015-04-13	82	0
K143639	IMMULITE 2000 CEA Calibration Verification Material	Siemens Healthcare Diagnostics	2015-01-23	32	0
K140717	CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINA	Siemens Healthcare Diagnostics	2014-11-17	242	0
K133512	LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA	Siemens Healthcare Diagnostics	2014-01-02	48	0
K122539	MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM	Siemens Healthcare Diagnostics	2013-04-19	241	0
K130698	DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)	Siemens Healthcare Diagnostics	2013-04-05	22	0
K121981	ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY	Siemens Healthcare Diagnostics	2013-03-21	258	2
K123677	DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMI	Siemens Healthcare Diagnostics	2013-03-07	97	0
K123320	DIMENSION AMMONIA FLEX REAGENT CARTRIDGE	Siemens Healthcare Diagnostics	2013-02-15	112	0
K123321	DIMENSION CHEMISTRY III CALIBRATORY	Siemens Healthcare Diagnostics	2013-02-15	112	0
K122323	DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CAR	Siemens Healthcare Diagnostics	2012-08-28	27	1
K121907	DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMEN	Siemens Healthcare Diagnostics	2012-07-23	24	0
K113216	RAPIDPOINT 500 BLOOD GAS ANALYER	Siemens Healthcare Diagnostics	2012-05-03	184	10
K102644	ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I	Siemens Healthcare Diagnostics	2011-11-23	435	1
K112999	DIMENSION CLINICAL CHEMISTRY SYSTEM	Siemens Healthcare Diagnostics	2011-11-22	46	5
K112142	DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE	Siemens Healthcare Diagnostics	2011-11-04	101	1
K110061	CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MAT	Siemens Healthcare Diagnostics	2011-09-21	254	0
K110934	ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATM	Siemens Healthcare Diagnostics	2011-08-25	143	1
K110277	RAPIDPOINT 405 NEONATAL BILIRUBIN	Siemens Healthcare Diagnostics	2011-08-15	196	4
K101572	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	Siemens Healthcare Diagnostics	2011-08-01	423	4
K110303	STRATUS CS ACUTE CARE D-DIMER	Siemens Healthcare Diagnostics	2011-05-16	104	1
K102510	DIMENSIONS HB1C KIT, MODEL DF105A	Siemens Healthcare Diagnostics	2011-05-13	259	1
K103683	IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION	Siemens Healthcare Diagnostics	2011-04-28	132	0
K100344	DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSI	Siemens Healthcare Diagnostics	2011-04-18	437	1
K100321	DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMEN	Siemens Healthcare Diagnostics	2011-04-12	432	0
K110169	DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSIO	Siemens Healthcare Diagnostics	2011-04-07	77	0
K101854	ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODEL	Siemens Healthcare Diagnostics	2011-03-07	249	0
K093626	INNOVANCE D-DIMER, MODEL OPBP09	Siemens Healthcare Diagnostics	2010-11-29	370	0
K102904	ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL	Siemens Healthcare Diagnostics	2010-11-23	53	0
K093107	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	Siemens Healthcare Diagnostics	2010-09-30	364	0
K101425	MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL S	Siemens Healthcare Diagnostics	2010-09-10	113	0
K100200	ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138	Siemens Healthcare Diagnostics	2010-08-02	189	1
K090346	ADVIA 2120/2120I BODY FLUIDS	Siemens Healthcare Diagnostics	2010-07-28	532	0
K101460	LOCI 8 CALIBRATOR, MODEL KC 646	Siemens Healthcare Diagnostics	2010-07-09	44	1
K093939	ADVIA CHEMISTRY SALICYLATE REAGENT	Siemens Healthcare Diagnostics	2010-05-19	148	0
K100433	IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULI	Siemens Healthcare Diagnostics	2010-05-13	86	0
K100289	ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY,	Siemens Healthcare Diagnostics	2010-05-10	97	0
K100778	DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A	Siemens Healthcare Diagnostics	2010-05-05	47	0
K093441	DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN),	Siemens Healthcare Diagnostics	2010-04-07	153	2
K093732	ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770	Siemens Healthcare Diagnostics	2010-03-22	108	1
K093645	EXL ANEM CAL, MODEL RC640	Siemens Healthcare Diagnostics	2010-03-05	100	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