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

Microlife Corp. — Predicate Candidate Screening

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

90 daysmedian FDA review time

228 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K122013	MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR	Microlife Corp.	2013-05-13	307
K080337	MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR	Microlife Corp.	2008-05-13	95
K073397	MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3	Microlife Corp.	2007-12-20	17
K073398	MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3	Microlife Corp.	2007-12-20	17
K041411	MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP	Microlife Corp.	2004-07-21	55
K031024	MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100	Microlife Corp.	2003-11-14	228
K030961	MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921	Microlife Corp.	2003-09-12	169
K021305	MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH	Microlife Corp.	2002-06-28	65
K020725	MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1	Microlife Corp.	2002-03-12	6
K013485	MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL	Microlife Corp.	2002-01-17	90
K003308	MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1,	Microlife Corp.	2000-11-14	22
K000969	MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1	Microlife Corp.	2000-08-22	148
K001182	MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1	Microlife Corp.	2000-08-01	112

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