Data / Medical devices / Japan / A&D Company, Limited - Tech Center
A&D Company, Limited - Tech Center: FDA-registered device maker in Kitamoto-shi Saitama, Japan, 15 510(k) clearances
A&D Company, Limited - Tech Center is registered with the FDA (registration 3003864328) in Kitamoto-shi Saitama, Japan. It lists 5 device types. The FDA files 15 510(k) clearances under its listings, the newest dated October 6, 2022. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003864328
- Address
- 1-243 Asahi, Kitamoto-shi Saitama, Japan, 364-8585
- Owner or operator
- A&D Company, Limited (8031633)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- September 9, 2005
- Registered through
- 2027
- Brand names listed
- A&D Medical UB-543, A&D Medical UM-211 Digital Blood Pressure Monitor, Digital Blood Pressure Monitor, System, Measurement, Blood Pressure Non-invasive, TM-2440 & TM-2441, TM-CF602D, TM-CF702D, UA-1020 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Blood Pressure Cuff | DXQ | 2 | Specification developer | accessdata.fda.gov |
| Scale, Patient | FRW | 1 | Specification developer | accessdata.fda.gov |
| Scale, Stand-On, Patient | FRI | 1 | Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 6, 2022 | K212168 | A&D Medical UM-212BLE Blood Pressure Monitor | DXN | Substantially Equivalent | A&D Company, Ltd. | accessdata.fda.gov |
| April 24, 2019 | K173065 | A&D Medical Blood Pressure Monitors | DXN | Substantially Equivalent | A&D Company, Ltd. | accessdata.fda.gov |
| March 21, 2019 | K173191 | A&D Medical Blood Pressure Monitors | DXN | Substantially Equivalent | A&D Company, Ltd. | accessdata.fda.gov |
| May 17, 2017 | K170196 | A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor | DXN | Substantially Equivalent | A&D Company, Ltd. | accessdata.fda.gov |
| May 3, 2017 | K163683 | A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor | DXN | Substantially Equivalent | A&D Company, Ltd. | accessdata.fda.gov |
| April 13, 2016 | K151953 | A&D Medical TM-2657 Family of Digital Blood Pressure Monitors | DXN | Substantially Equivalent | A&D Company, Ltd. | accessdata.fda.gov |
| October 8, 2014 | K141201 | A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | A & D Co., Ltd. | accessdata.fda.gov |
| October 7, 2014 | K141160 | A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | A & D Co., Ltd. | accessdata.fda.gov |
| June 27, 2014 | K141179 | A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | A & D Co., Ltd. | accessdata.fda.gov |
| August 1, 2011 | K111686 | A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS | DXN | Substantially Equivalent | A&D Company, Ltd. | accessdata.fda.gov |
| January 19, 2007 | K062027 | A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | A&D Engineering, Inc. | accessdata.fda.gov |
| March 3, 2005 | K043217 | A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | A&D Engineering, Inc. | accessdata.fda.gov |
| December 3, 2004 | K042967 | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 | DXN | Substantially Equivalent | A&D Engineering, Inc. | accessdata.fda.gov |
| October 30, 2003 | K032499 | A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS | DXN | Substantially Equivalent | A&D Engineering, Inc. | accessdata.fda.gov |
| February 15, 2002 | K012472 | A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS | DXN | Substantially Equivalent | A&D Engineering, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Scale, Patient
- All makers of Analyzer, Body Composition, Exempt
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Scale, Stand-On, Patient
- All makers of Blood Pressure Cuff
Updated October 6, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.