A&D Engineering, Inc.: FDA filings under this applicant name
FDA lists 34 510(k) clearances under the applicant name “A&D Engineering, Inc.” (first 1987, latest 2008), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 82 days. 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 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 25 | 25 |
| DSK | Computer, Blood-Pressure | 6 | 6 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Review panels
- Cardiovascular (33)
- General Hospital (1)
Most recent A&D Engineering, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082734 | A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR | DXN | 2008-11-13 | 56 |
| K062027 | A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR | DXN | 2007-01-19 | 185 |
| K061456 | A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR | DXN | 2006-06-21 | 27 |
| K043217 | A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR | DXN | 2005-03-03 | 101 |
| K042967 | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 | DXN | 2004-12-03 | 36 |
| K040371 | A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR | DXN | 2004-05-19 | 92 |
| K040229 | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328 | DXN | 2004-03-19 | 46 |
| K032499 | A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS | DXN | 2003-10-30 | 78 |
| K012472 | A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS | DXN | 2002-02-15 | 197 |
| K012013 | LIFESOURCE MODELS UA-787, UA 787PC, UA-787T | DXN | 2001-07-13 | 15 |
24 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named A&D Engineering, Inc..
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 Engineering, Inc.?
FDA lists 34 510(k) clearances under the applicant name “A&D Engineering, Inc.” (first 1987, latest 2008), across 5 product codes in 2 review panels. 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 Engineering, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name A&D Engineering, Inc. is 82 days.
Which FDA product codes appear under A&D Engineering, Inc.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 25); DSK (Computer, Blood-Pressure, 6); DRQ (Amplifier And Signal Conditioner, Transducer Signal, 1).
Next steps
- See all 34 A&D Engineering, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXN, A&D Engineering, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.