Ya Horng Electronic Co., Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Ya Horng Electronic Co., Ltd.” (first 2004, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 51 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 | 1 | 135 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 99 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ya Horng Electronic Co., Ltd. took a median 99 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 9 | 9 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
Review panels
- Cardiovascular (10)
Most recent Ya Horng Electronic Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221486 | INDEX BPM | DXN | 2022-08-30 | 99 |
| K121025 | YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION | DXN | 2012-08-17 | 135 |
| K090058 | YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB | DXN | 2009-04-22 | 104 |
| K081590 | YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J | DXN | 2008-06-19 | 13 |
| K072860 | YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500 | DXN | 2008-02-25 | 143 |
| K051862 | PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR. | DXN | 2005-08-23 | 46 |
| K051863 | AMLUCK, YA HORNG | DXN | 2005-08-19 | 42 |
| K051539 | TRICOT BLOOD PRESSURE CUFF | DXQ | 2005-08-05 | 56 |
| K042581 | AMLUCK, YA HORNG | DXN | 2004-10-13 | 21 |
| K040528 | AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T | DXN | 2004-04-15 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Ya Horng Electronic Co., Ltd..
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 Ya Horng Electronic Co., Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Ya Horng Electronic Co., Ltd.” (first 2004, latest 2022), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ya Horng Electronic Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ya Horng Electronic Co., Ltd. is 51 days.
Which FDA product codes appear under Ya Horng Electronic Co., Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 9); DXQ (Blood Pressure Cuff, 1).
Next steps
- See all 10 Ya Horng Electronic Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Ya Horng Electronic Co., Ltd.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.