Data / Medical devices / United States / A&d Engineering, Inc.
A&d Engineering, Inc.: FDA-registered device maker in Ann Arbor, MI, United States, 15 510(k) clearances
A&d Engineering, Inc. is registered with the FDA (registration 2082313) in Ann Arbor, MI, United States. It lists 2 device types. The FDA files 15 510(k) clearances under its listings, the newest dated April 24, 2019. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2082313
- Address
- 4622 Runway Boulevard, Ann Arbor, MI, United States, 48108
- Owner or operator
- A&D Company, Limited (8031633)
- Roles
- Complaint file establishment, Remanufacturer, Repackager or relabeler
- 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, 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 |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| December 29, 2000 | K002182 | AVITA TSO/TS1 INFRARED EAR THERMOMETER | FLL | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 12, 2016 | 75177 | Class II | Terminated | Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate. | A&D may have shipped blood pressure monitors that were not labeled for use with small cuff. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Continuous Measurement Thermometer
Updated April 24, 2019. 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.