Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dongguan Simzo Electronic Technology Co., Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230379 | Portable (Ultrasonic) Nebulizer | Dongguan Simzo Electronic Technology Co., Ltd. | 2023-11-27 | 287 | 0 |
| K211583 | Infrared Thermometer, Model: HW-1 | Dongguan Simzo Electronic Technology Co., Ltd. | 2021-09-03 | 102 | 0 |
| K173048 | No-contact Forehead Thermometer | Dongguan Simzo Electronic Technology Co., Ltd. | 2018-12-06 | 434 | 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