Dongguan E-Test Technology Co., Ltd.: FDA clearances and approvals
Dongguan E-Test Technology Co., Ltd. has 5 FDA 510(k) clearances (first 2020, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time: 199 days. Since 2017 its median was 199 days, against 182 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 4 | 199 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 219 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Dongguan E-Test Technology Co., Ltd.'s cleared 510(k)s took a median 199 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 182 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 4 | 4 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Review panels
- Cardiovascular (4)
- General Hospital (1)
Most recent Dongguan E-Test Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250231 | Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) | DXN | 2025-09-03 | 219 |
| K193621 | Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) | FLL | 2020-11-23 | 333 |
| K193628 | AGE Automatic Wrist Blood Pressure Monitor | DXN | 2020-07-12 | 199 |
| K193627 | Automatic Upper Arm Blood Pressure Monitor | DXN | 2020-07-12 | 199 |
| K193624 | Automatic Upper Arm Blood Pressure Monitor | DXN | 2020-07-10 | 197 |
Recalls
openFDA lists no recalls under a recalling firm named Dongguan E-Test Technology Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Dongguan E-Test Technology Co., Ltd. have?
Dongguan E-Test Technology Co., Ltd. has 5 FDA 510(k) clearances (first 2020, latest 2025), across 2 product codes in 2 review panels.
How long does FDA take to clear Dongguan E-Test Technology Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Dongguan E-Test Technology Co., Ltd.'s cleared 510(k)s is 199 days. Since 2017: 199 days, versus 182 days for all cleared 510(k)s in the same product codes.
What devices does Dongguan E-Test Technology Co., Ltd. make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 4); FLL (Continuous Measurement Thermometer, 1).
Has Dongguan E-Test Technology Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dongguan E-Test Technology Co., Ltd. Related entities may recall under other names.
Next steps
- See all 5 Dongguan E-Test Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Dongguan E-Test Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.