Data / Medical devices / United States / A&D Engineering, Inc.
A&D Engineering, Inc.: FDA-registered device maker in Duluth, GA, United States, 17 510(k) clearances
A&D Engineering, Inc. is registered with the FDA (registration 1054421) in Duluth, GA, United States. It lists 6 device types. The FDA files 17 510(k) clearances under its listings, the newest dated October 6, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1054421
- FEI number
- 1000110823
- Address
- 2605 N.Berkeley Lake Rd. Bldg 100, ste 350, Duluth, GA, United States, 30096
- Owner or operator
- A&D Company, Limited (8031633)
- Roles
- Complaint file establishment, Remanufacturer, Repackager or relabeler
- First device listed
- September 9, 2005
- Registered through
- 2026
- Brand names listed
- A&D Medical UB-543, A&D Medical UM-211 Digital Blood Pressure Monitor, DT-102, DT-103, DT-105 Thermometer, Digital Blood Pressure Monitor, System, Measurement, Blood Pressure Non-invasive, TM-2440 & TM-2441 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Blood Pressure Cuff | DXQ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Scale, Patient | FRW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scale, Stand-On, Patient | FRI | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment, Remanufacturer, Repackager or relabeler | 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 |
| September 19, 2017 | K163518 | Digital Thermometer | FLL | Substantially Equivalent | Joytech Healthcare Co. , 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 7, 2010 | K092447 | DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES | FLL | Substantially Equivalent | Hangzhou Hua'An Medical & Health Instruments Co., | 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 |
| 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 |
| December 29, 2000 | K002182 | AVITA TSO/TS1 INFRARED EAR THERMOMETER | FLL | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Blood Pressure Cuff
- All makers of Analyzer, Body Composition, Exempt
- All makers of Continuous Measurement Thermometer
- All makers of Scale, Patient
- All makers of Scale, Stand-On, Patient
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.