Company · CN
Andon Health Co, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2025. Name variants (Inc, Corp, punctuation) are merged.
92510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 68 |
| NBW | System, Test, Blood Glucose, Over The Counter | 8 |
| FLL | Continuous Measurement Thermometer | 5 |
| DQA | Oximeter | 2 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 |
| DPS | Electrocardiograph | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 |
| DXQ | Blood Pressure Cuff | 1 |
| FXX | Mask, Surgical | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 |
| MNW | Analyzer, Body Composition | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 4, 2025 | K251113 | iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);i Andon Health Co, Ltd., CN | DXN |
| Dec 20, 2024 | K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip Andon Health Co, Ltd., CN | LCX |
| Apr 22, 2024 | K234041 | Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-581 Andon Health Co, Ltd., CN | DXN |
| Feb 15, 2023 | K222869 | Arm Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| Dec 21, 2022 | K222867 | AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) Andon Health Co, Ltd., CN | NUH |
| Jan 28, 2022 | K212598 | iHealth infrared Ear thermometer PT5 Andon Health Co, Ltd., CN | FLL |
| Jul 30, 2021 | K210768 | Wrist Blood Pressure Monitor, Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| Jul 29, 2021 | K210770 | Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| Mar 8, 2021 | K202753 | iHealth Wireless No-Touch Forehead Thermometer Andon Health Co, Ltd., CN | FLL |
| Jan 5, 2021 | K202791 | iHealth Clinical Digital Thermometer Andon Health Co, Ltd., CN | FLL |
| Oct 7, 2020 | K201380 | Livocare Surgical Mask Andon Health Co, Ltd., CN | FXX |
| Oct 1, 2020 | K200710 | Infrared PT2L Digital No-Touch Thermometer Andon Health Co, Ltd., CN | FLL |
| Jul 15, 2020 | K200531 | iHealth Infrared No-Touch Forehead Thermometer Andon Health Co, Ltd., CN | FLL |
| Jun 4, 2019 | K183535 | Fully Automatic Electronic Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| May 16, 2019 | K183534 | Fully Automatic Electronic Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| Apr 16, 2019 | K181541 | Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth N Andon Health Co, Ltd., CN | MWI |
| Feb 1, 2019 | K181070 | iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) Andon Health Co, Ltd., CN | NBW |
| Jul 24, 2018 | K172862 | Portable ECG Monitor (ECG3) Andon Health Co, Ltd., CN | DSH |
| Sep 15, 2017 | K170231 | iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5) Andon Health Co, Ltd., CN | NBW |
| Aug 1, 2017 | K171062 | BP5S Wireless Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| Jul 27, 2017 | K171282 | Fully Automatic Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| May 11, 2017 | K163276 | Fully Automatic Electronic Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| Feb 16, 2017 | K153561 | AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System Andon Health Co, Ltd., CN | NBW |
| Feb 14, 2017 | K162668 | Fully Automatic Electronic Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| Feb 8, 2017 | K162915 | Fully Automatic Electronic Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| Feb 1, 2017 | K162144 | iHealth Wireless Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| Aug 19, 2016 | K153286 | iHealth Align Gluco-Monitoring system Andon Health Co, Ltd., CN | NBW |
| Aug 19, 2016 | K153278 | Wireless Smart Gluco-Monitoring System Andon Health Co, Ltd., CN | NBW |
| Aug 10, 2016 | K160565 | Fully Automatic Electronic Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| Aug 4, 2016 | K160563 | Fully Automatic Electronic Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| Feb 2, 2016 | K160014 | iHealth Track Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| Dec 4, 2015 | K150833 | iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart G Andon Health Co, Ltd., CN | NBW |
| Sep 24, 2015 | K152003 | iHealth BP3L Wireless Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| Sep 23, 2015 | K152379 | iHealth View BP7S Wireless Blood Pressure Wrist Monitor Andon Health Co, Ltd., CN | DXN |
| Sep 8, 2015 | K151460 | Fully Automatic Electronic Blood Pressure Monitor Andon Health Co, Ltd., CN | DXN |
| Aug 14, 2015 | K150043 | Transcutaneous Electrical Nerve Stimulators (TENS) Andon Health Co, Ltd., CN | NUH |
| Apr 29, 2015 | K141984 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Health Co, Ltd., CN | DXN |
| Jul 2, 2014 | K140121 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Health Co, Ltd., CN | DXN |
| May 22, 2014 | K133790 | IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM Andon Health Co, Ltd., CN | NBW |
| Mar 4, 2014 | K133117 | ANDON BLOOD PRESSURE CUFF Andon Health Co, Ltd., CN | DXQ |
| Sep 11, 2013 | K131111 | IHEALTH FINGERTIP PULSE OXIMETER Andon Health Co, Ltd., CN | DQA |
| Jul 19, 2013 | K131203 | IHEALTH CLOUD Andon Health Co, Ltd., CN | DXN |
| Mar 21, 2013 | K122098 | APPS-HEALTH01 Andon Health Co, Ltd., CN | DXN |
| Oct 15, 2012 | K121697 | FINGERTIP PULSE OXIMETER Andon Health Co, Ltd., CN | DQA |
| Sep 10, 2012 | K121372 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Health Co, Ltd., CN | DXN |
| Jul 26, 2012 | K120896 | WI-FI BODY SCALE Andon Health Co, Ltd., CN | MNW |
| Jun 14, 2012 | K121470 | FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR Andon Health Co, Ltd., CN | DXN |
| Jun 1, 2012 | K120672 | KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR Andon Health Co, Ltd. | DXN |
| Dec 9, 2011 | K111830 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO Andon Health Co, Ltd., CN | DXN |
| Dec 9, 2011 | K111826 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Health Co, Ltd., CN | DXN |
Newest 50 of 92.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||