Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ya Horng Electronic Co., Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
143 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221486 | INDEX BPM | Ya Horng Electronic Co., Ltd. | 2022-08-30 | 99 | 0 |
| K121025 | YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MON | Ya Horng Electronic Co., Ltd. | 2012-08-17 | 135 | 0 |
| K090058 | YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, B | Ya Horng Electronic Co., Ltd. | 2009-04-22 | 104 | 0 |
| K081590 | YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP- | Ya Horng Electronic Co., Ltd. | 2008-06-19 | 13 | 0 |
| K072860 | YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, | Ya Horng Electronic Co., Ltd. | 2008-02-25 | 143 | 0 |
| K051862 | PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-41 | Ya Horng Electronic Co., Ltd. | 2005-08-23 | 46 | 0 |
| K051863 | AMLUCK, YA HORNG | Ya Horng Electronic Co., Ltd. | 2005-08-19 | 42 | 0 |
| K051539 | TRICOT BLOOD PRESSURE CUFF | Ya Horng Electronic Co., Ltd. | 2005-08-05 | 56 | 0 |
| K042581 | AMLUCK, YA HORNG | Ya Horng Electronic Co., Ltd. | 2004-10-13 | 21 | 0 |
| K040528 | AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, | Ya Horng Electronic Co., Ltd. | 2004-04-15 | 45 | 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