Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dongguan E-Test Technology Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
199 daysmedian FDA review time
333 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250231 | Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X | Dongguan E-Test Technology Co., Ltd. | 2025-09-03 | 219 | 0 |
| K193621 | Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, B | Dongguan E-Test Technology Co., Ltd. | 2020-11-23 | 333 | 0 |
| K193628 | AGE Automatic Wrist Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. | 2020-07-12 | 199 | 0 |
| K193627 | Automatic Upper Arm Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. | 2020-07-12 | 199 | 4 |
| K193624 | Automatic Upper Arm Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. | 2020-07-10 | 197 | 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