Medical device manufacturer
Andon Health Co, Ltd.
Andon Health Co, Ltd. holds 92 FDA 510(k) clearances across 12 product codes. Median elapsed review time is 114 days. openFDA lists no recall records naming the company. FDA publishes it under 2 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 92
- Product codes
- 12
- Median review
- 114 days
- Recall records
- 0
How does FDA spell Andon Health Co, Ltd.?
FDA publishes this company under 2 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| ANDON HEALTH CO., LTD | device/registrationlisting | normalised |
| Andon Health Co, Ltd. | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Andon Health Co, Ltd. file in?
12 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 68 | 85 days | |
| NBW | System, Test, Blood Glucose, Over The Counter | 8 | 269 days | |
| FLL | Continuous Measurement Thermometer | 5 | 165 days | |
| DQA | Oximeter | 2 | 130 days | |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | 90 days | |
| DPS | Electrocardiograph | 1 | 162 days | |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 307 days | |
| DXQ | Blood Pressure Cuff | 1 | 155 days | |
| FXX | Mask, Surgical | 1 | 134 days | |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 218 days | |
| MNW | Analyzer, Body Composition | 1 | 122 days | |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 | 309 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Andon Health Co, Ltd. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Andon Health Co, Ltd. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed 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 | 115 | |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | LCX | 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 | 123 | |
| K222869 | Arm Blood Pressure Monitor | DXN | 146 | |
| K222867 | AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) | NUH | 90 | |
| K212598 | iHealth infrared Ear thermometer PT5 | FLL | 165 | |
| K210768 | Wrist Blood Pressure Monitor, Blood Pressure Monitor | DXN | 137 | |
| K210770 | Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor | DXN | 136 | |
| K202753 | iHealth Wireless No-Touch Forehead Thermometer | FLL | 168 | |
| K202791 | iHealth Clinical Digital Thermometer | FLL | 105 |
Source: openFDA device/510k · retrieved
Where is Andon Health Co, Ltd. registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Andon Health Co, Ltd. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.