A and D Engineering, Inc.
Duluth, GA, US
A and D Engineering, Inc. appears in FDA device records in Duluth, GA. FDA records list 34 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to A and D Engineering, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- A & D Enginering Incenforcement report, recall
510(k) clearance history
FDA records hold 34 510(k) clearances for A and D Engineering, Inc. between 1987 and 2008. The busiest year on record is 1987, with 6. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 6 |
| 1988 | 2 |
| 1989 | 4 |
| 1991 | 3 |
| 1993 | 1 |
| 1996 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K082734 | A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K062027 | A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K061456 | A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K043217 | A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K042967 | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 | DXN | Substantially Equivalent | |
| K040371 | A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K040229 | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328 | DXN | Substantially Equivalent | |
| K032499 | A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS | DXN | Substantially Equivalent | |
| K012472 | A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS | DXN | Substantially Equivalent | |
| K012013 | LIFESOURCE MODELS UA-787, UA 787PC, UA-787T | DXN | Substantially Equivalent | |
| K010828 | DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP | DXN | Substantially Equivalent | |
| K002061 | A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR | DRT | Substantially Equivalent | |
| K002115 | A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS | DXN | Substantially Equivalent | |
| K993116 | A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER | FLL | Substantially Equivalent | |
| K993888 | A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS | DXN | Substantially Equivalent | |
| K982481 | A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K980824 | A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K960319 | A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K914273 | A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR | DSK | Substantially Equivalent | |
| K912119 | DIGITAL SPHYGMOMANOMETER MODEL UB-211 AND 212 | DXN | Substantially Equivalent | |
| K912118 | DIGITAL SPHYGMOMANOMETER MODEL UA-833 | DXN | Substantially Equivalent | |
| K911049 | DIGITAL SPHYGMOIMANOMETER, MODEL UA-830 | DXN | Substantially Equivalent | |
| K895429 | A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2650 | DXN | Substantially Equivalent | |
| K895428 | A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2510/20 | DXN | Substantially Equivalent | |
| K882825 | TAKEDA MEDICAL AUTO. DIG. BLOOD PRES. METER W/PRIN | DXN | Substantially Equivalent | |
| K882824 | TAKEDA MEDICAL AUTO. DIGITAL BLOOD PRES. MONITOR | DXN | Substantially Equivalent | |
| K880079 | TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420 | DSK | Substantially Equivalent | |
| K874338 | TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610 | DSK | Substantially Equivalent | |
| K874339 | TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620 | DSK | Substantially Equivalent | |
| K872629 | TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER/ UA-741 | DXN | Substantially Equivalent | |
| K871720 | MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER | DSK | Substantially Equivalent | |
| K871718 | MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER | DSK | Substantially Equivalent | |
| K871719 | MODIFIED MODEL UA-751 DIGITAL SPHYGMONOMETER | DXN | Substantially Equivalent | |
| K870728 | TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701 | DRQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3044174020 | 3044174020 | A and D Engineering, Inc. | 1075 Highway 124W, Hoschton, GA 30548 US | 2026 | |
| 2082313 | 2082313 | A&D ENGINEERING, INC. | 4622 Runway Boulevard, Ann Arbor, MI 48108 US | 2026 | |
| 1054421 | 1000110823 | A&D Engineering, Inc. | 2605 N.Berkeley Lake Rd., Duluth, GA 30096 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DRQAmplifier And Signal Conditioner, Transducer Signal
- PUHAnalyzer, Body Composition, Exempt
- DXQBlood Pressure Cuff
- DSKComputer, Blood-Pressure
- FLLContinuous Measurement Thermometer
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- FRWScale, Patient
- FRIScale, Stand-On, Patient
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0063-2017 | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain