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

Aalto Scientific, Ltd. · Predicate Candidate Screening

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

66 daysmedian FDA review time

268 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K163629	Audit MicroControls Linearity FD Tumor Markers II	Aalto Scientific, Ltd.	2017-03-10	78	0
K161874	Audit MicroControls Linearity DROP LQ Blood Glucose	Aalto Scientific, Ltd.	2016-08-10	33	0
K143571	Audit MicroControls Linearity LQ Cystatin-C	Aalto Scientific, Ltd.	2015-01-23	37	0
K143573	Audit MicroControls Linearity FD Tumor Markers II	Aalto Scientific, Ltd.	2015-01-16	30	0
K143026	Audit MicroControls Linearity FD Unsaturated Iron Binding Ca	Aalto Scientific, Ltd.	2014-11-21	31	0
K142978	Audit MicroControls Linearity LQ Special Diabetes	Aalto Scientific, Ltd.	2014-11-20	36	0
K130762	AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET	Aalto Scientific, Ltd.	2013-04-29	40	0
K130764	AUDIT MICROCV VITAMIN D LINEARITY SET	Aalto Scientific, Ltd.	2013-04-26	37	0
K130157	AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET	Aalto Scientific, Ltd.	2013-03-19	55	0
K112742	AUDIT MICROLQ SPINAL FLUID CONTROL	Aalto Scientific, Ltd.	2012-06-15	268	0
K111964	AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY	Aalto Scientific, Ltd.	2012-03-02	235	0
K112143	AUDIT MICROCV T-UPTAKE LINEARITY	Aalto Scientific, Ltd.	2012-01-31	189	0
K112705	AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL	Aalto Scientific, Ltd.	2012-01-24	130	0
K100716	AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5	Aalto Scientific, Ltd.	2011-06-23	468	0
K103601	AUDIT MICROCV IMMUNOASSAY LINEARITY SET	Aalto Scientific, Ltd.	2011-06-10	184	0
K101216	AUDIT MICROCV PROTEIN LINEARITY SET	Aalto Scientific, Ltd.	2011-01-14	259	0
K102617	AUDIT MICROCV CARDIAC MARKERS LINEARITY SET	Aalto Scientific, Ltd.	2011-01-10	122	0
K100715	AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5	Aalto Scientific, Ltd.	2010-12-23	286	0
K101427	AUDIT MICROCV HS-CRP LINEARITY SET	Aalto Scientific, Ltd.	2010-12-23	216	0
K100718	AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5	Aalto Scientific, Ltd.	2010-09-03	175	0
K101226	AUDIT MICROCV RF/CRP LINEARITY SET	Aalto Scientific, Ltd.	2010-08-31	120	0
K101434	AUDIT MICROCV PROCALCITONIN LINEARITY	Aalto Scientific, Ltd.	2010-07-22	62	0
K100750	AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5	Aalto Scientific, Ltd.	2010-05-21	66	0
K082714	AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K7	Aalto Scientific, Ltd.	2008-11-19	63	0
K082717	AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5	Aalto Scientific, Ltd.	2008-10-30	43	0
K070223	AUDIT MICROCV LIPIDS LINEARITY SET (LOW)	Aalto Scientific, Ltd.	2007-03-13	48	0
K062668	AUDIT MICROCV IMMUNOASSAY LINEARITY SET	Aalto Scientific, Ltd.	2006-10-16	38	0
K042318	AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET	Aalto Scientific, Ltd.	2004-12-09	105	0
K032122	AUDIT MICROCONTROLS MICROFD BNP CONTROL	Aalto Scientific, Ltd.	2003-09-09	62	0
K020618	AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL	Aalto Scientific, Ltd.	2002-05-14	78	0
K952126	AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS	Aalto Scientific, Ltd.	1996-02-29	297	0
K954074	AALTO SCIENTIFIC LIQUID CARDIAC CONTROL	Aalto Scientific, Ltd.	1995-10-07	38	0
K952720	AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I &	Aalto Scientific, Ltd.	1995-09-20	97	3
K951435	AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL	Aalto Scientific, Ltd.	1995-05-02	36	0
K820360	AALTO LDH ISOENZYME CONTROL SERUM	Aalto Scientific, Ltd.	1982-03-04	23	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