Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A&D Company, Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
273 daysmedian FDA review time
572 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212168 | A&D Medical UM-212BLE Blood Pressure Monitor | A&D Company, Ltd. | 2022-10-06 | 451 | 0 |
| K173065 | A&D Medical Blood Pressure Monitors | A&D Company, Ltd. | 2019-04-24 | 572 | 0 |
| K173191 | A&D Medical Blood Pressure Monitors | A&D Company, Ltd. | 2019-03-21 | 535 | 0 |
| K170196 | A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure M | A&D Company, Ltd. | 2017-05-17 | 114 | 0 |
| K163683 | A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure M | A&D Company, Ltd. | 2017-05-03 | 126 | 0 |
| K151953 | A&D Medical TM-2657 Family of Digital Blood Pressure Monitor | A&D Company, Ltd. | 2016-04-13 | 273 | 0 |
| K111686 | A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS | A&D Company, Ltd. | 2011-08-01 | 46 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda