Atlas FDA

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

Andon Health Co, Ltd. · Predicate Candidate Screening

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

115 daysmedian FDA review time
248 days90th percentile
92clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251113iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHeAndon Health Co, Ltd.2025-08-041150
K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy TestAndon Health Co, Ltd.2024-12-202180
K234041Fully Automatic Electronic Blood Pressure Monitor (KD-5811VAAndon Health Co, Ltd.2024-04-221230
K222869Arm Blood Pressure MonitorAndon Health Co, Ltd.2023-02-151460
K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.2022-12-21900
K212598iHealth infrared Ear thermometer PT5Andon Health Co, Ltd.2022-01-281650
K210768Wrist Blood Pressure Monitor, Blood Pressure MonitorAndon Health Co, Ltd.2021-07-301370
K210770Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorAndon Health Co, Ltd.2021-07-291360
K202753iHealth Wireless No-Touch Forehead ThermometerAndon Health Co, Ltd.2021-03-081680
K202791iHealth Clinical Digital ThermometerAndon Health Co, Ltd.2021-01-051050
K201380Livocare Surgical MaskAndon Health Co, Ltd.2020-10-071340
K200710Infrared PT2L Digital No-Touch ThermometerAndon Health Co, Ltd.2020-10-011970
K200531iHealth Infrared No-Touch Forehead ThermometerAndon Health Co, Ltd.2020-07-151350
K183535Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.2019-06-041670
K183534Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.2019-05-161480
K181541Connect App for iHealth Next, iHealth React Native SDK, iHeaAndon Health Co, Ltd.2019-04-163090
K181070iHealth Wireless Smart Gluco-Monitoring System (iHealth GlucAndon Health Co, Ltd.2019-02-012840
K172862Portable ECG Monitor (ECG3)Andon Health Co, Ltd.2018-07-243070
K170231iHealth Align Gluco-Monitoring System (BG1); iHealth WirelesAndon Health Co, Ltd.2017-09-152330
K171062BP5S Wireless Blood Pressure MonitorAndon Health Co, Ltd.2017-08-011130
K171282Fully Automatic Blood Pressure MonitorAndon Health Co, Ltd.2017-07-27870
K163276Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.2017-05-111710
K153561AG-607 Blood Glucose Monitoring System and AG-607 Multi BlooAndon Health Co, Ltd.2017-02-164300
K162668Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.2017-02-141410
K162915Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.2017-02-081140
K162144iHealth Wireless Blood Pressure MonitorAndon Health Co, Ltd.2017-02-011840
K153286iHealth Align Gluco-Monitoring systemAndon Health Co, Ltd.2016-08-192810
K153278Wireless Smart Gluco-Monitoring SystemAndon Health Co, Ltd.2016-08-192810
K160565Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.2016-08-101630
K160563Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.2016-08-041570
K160014iHealth Track Blood Pressure MonitorAndon Health Co, Ltd.2016-02-02290
K150833iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Andon Health Co, Ltd.2015-12-042490
K152003iHealth BP3L Wireless Blood Pressure MonitorAndon Health Co, Ltd.2015-09-24660
K152379iHealth View BP7S Wireless Blood Pressure Wrist MonitorAndon Health Co, Ltd.2015-09-23330
K151460Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.2015-09-08990
K150043Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.2015-08-142170
K141984FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORAndon Health Co, Ltd.2015-04-292820
K140121FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORAndon Health Co, Ltd.2014-07-021670
K133790IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEMAndon Health Co, Ltd.2014-05-221640
K133117ANDON BLOOD PRESSURE CUFFAndon Health Co, Ltd.2014-03-041550
K131111IHEALTH FINGERTIP PULSE OXIMETERAndon Health Co, Ltd.2013-09-111450
K131203IHEALTH CLOUDAndon Health Co, Ltd.2013-07-19810
K122098APPS-HEALTH01Andon Health Co, Ltd.2013-03-212480
K121697FINGERTIP PULSE OXIMETERAndon Health Co, Ltd.2012-10-151300
K121372FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORAndon Health Co, Ltd.2012-09-101260
K120896WI-FI BODY SCALEAndon Health Co, Ltd.2012-07-261220
K121470FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITORAndon Health Co, Ltd.2012-06-14280
K120672KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITORAndon Health Co, Ltd.2012-06-01880
K111830FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7Andon Health Co, Ltd.2011-12-091640
K111826FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORAndon Health Co, Ltd.2011-12-091640

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