Andon Medical Co., Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Andon Medical Co., Ltd.” (first 2010, latest 2013), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 267 days. 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 | 2 | 322 |
| 2013 | 1 | 113 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 8 | 8 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
Review panels
- Clinical Chemistry (8)
- Cardiovascular (1)
Most recent Andon Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123935 | IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM | NBW | 2013-04-12 | 113 |
| K120813 | BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2012-12-07 | 263 |
| K110017 | AG-608N BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2012-01-18 | 380 |
| K112738 | ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE | NBW | 2011-09-30 | 10 |
| K102678 | ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS | NBW | 2011-08-26 | 344 |
| K101307 | BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 | NBW | 2011-08-09 | 456 |
| K093755 | AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2011-07-15 | 585 |
| K102609 | KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | DXN | 2010-12-09 | 90 |
| K093262 | AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2010-07-13 | 267 |
Recalls
openFDA lists no recalls under a recalling firm named Andon Medical 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.
Device clinical trials
An industry sponsor named Andon Medical Co., Ltd. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01268345: AST Clinical Investigation (Completed, started 2010-10)
- NCT00976924: Clinical Test of Blood Glucose Test Strips (Completed, started 2009-07)
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 Health Co, Ltd. (92 510(k)s)
- Andon Medical Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Andon Medical Co., Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Andon Medical Co., Ltd.” (first 2010, latest 2013), across 2 product codes in 2 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 Medical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Andon Medical Co., Ltd. is 267 days.
Which FDA product codes appear under Andon Medical Co., Ltd.?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 8); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1).
Next steps
- See all 9 Andon Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Andon Medical 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.