A&D Company, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “A&D Company, Ltd.” (first 2011, latest 2022), across 1 product code in 1 review panel. Median 510(k) review time under this name: 273 days. Since 2017 the median was 451 days, against 162 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 273 |
| 2017 | 2 | 120 |
| 2018 | 0 | — |
| 2019 | 2 | 554 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 451 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name A&D Company, Ltd. took a median 451 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 7 | 7 |
Review panels
- Cardiovascular (7)
Most recent A&D Company, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212168 | A&D Medical UM-212BLE Blood Pressure Monitor | DXN | 2022-10-06 | 451 |
| K173065 | A&D Medical Blood Pressure Monitors | DXN | 2019-04-24 | 572 |
| K173191 | A&D Medical Blood Pressure Monitors | DXN | 2019-03-21 | 535 |
| K170196 | A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor | DXN | 2017-05-17 | 114 |
| K163683 | A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor | DXN | 2017-05-03 | 126 |
| K151953 | A&D Medical TM-2657 Family of Digital Blood Pressure Monitors | DXN | 2016-04-13 | 273 |
| K111686 | A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS | DXN | 2011-08-01 | 46 |
Recalls
openFDA lists no recalls under a recalling firm named A&D Company, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under A&D Company, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “A&D Company, Ltd.” (first 2011, latest 2022), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by A&D Company, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name A&D Company, Ltd. is 273 days. Since 2017: 451 days, versus 162 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under A&D Company, Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 7).
Next steps
- See all 7 A&D Company, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, A&D Company, 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.