Andon Health Co, Ltd.: FDA filings under this applicant name
FDA lists 92 510(k) clearances under the applicant name “Andon Health Co, Ltd.” (first 2008, latest 2025), across 12 product codes in 6 review panels. Median 510(k) review time under this name: 114 days. Since 2017 the median was 147 days, against 171 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 122 |
| 2013 | 3 | 145 |
| 2014 | 3 | 164 |
| 2015 | 6 | 158 |
| 2016 | 5 | 163 |
| 2017 | 8 | 156 |
| 2018 | 1 | 307 |
| 2019 | 4 | 226 |
| 2020 | 3 | 135 |
| 2021 | 4 | 136 |
| 2022 | 2 | 128 |
| 2023 | 1 | 146 |
| 2024 | 2 | 170 |
| 2025 | 1 | 115 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Andon Health Co, Ltd. took a median 147 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 171 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 68 | 68 |
| NBW | System, Test, Blood Glucose, Over The Counter | 8 | 8 |
| FLL | Continuous Measurement Thermometer | 5 | 5 |
| DQA | Oximeter | 2 | 2 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
Plus 2 more product codes.
Review panels
- Cardiovascular (72)
- Clinical Chemistry (9)
- General Hospital (6)
- Anesthesiology (2)
- Neurology (2)
- Gastroenterology and Urology (1)
Most recent Andon Health Co, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251113 | iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr | DXN | 2025-08-04 | 115 |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | LCX | 2024-12-20 | 218 |
| K234041 | Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) | DXN | 2024-04-22 | 123 |
| K222869 | Arm Blood Pressure Monitor | DXN | 2023-02-15 | 146 |
| K222867 | AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) | NUH | 2022-12-21 | 90 |
| K212598 | iHealth infrared Ear thermometer PT5 | FLL | 2022-01-28 | 165 |
| K210768 | Wrist Blood Pressure Monitor, Blood Pressure Monitor | DXN | 2021-07-30 | 137 |
| K210770 | Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor | DXN | 2021-07-29 | 136 |
| K202753 | iHealth Wireless No-Touch Forehead Thermometer | FLL | 2021-03-08 | 168 |
| K202791 | iHealth Clinical Digital Thermometer | FLL | 2021-01-05 | 105 |
82 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Andon Health Co, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Andon Medical Co., Ltd. (9 510(k)s)
- Andon Medical Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Andon Health Co, Ltd.?
FDA lists 92 510(k) clearances under the applicant name “Andon Health Co, Ltd.” (first 2008, latest 2025), across 12 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Andon Health Co, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Andon Health Co, Ltd. is 114 days. Since 2017: 147 days, versus 171 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Andon Health Co, Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 68); NBW (System, Test, Blood Glucose, Over The Counter, 8); FLL (Continuous Measurement Thermometer, 5).
Next steps
- See all 92 Andon Health Co, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Andon Health Co, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.