Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hetaida Technology Co., Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
332 daysmedian FDA review time
420 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243661 | Electronic Blood Pressure Monitor | Hetaida Technology Co., Ltd. | 2025-02-07 | 72 | 0 |
| K241202 | Electric nasal aspirator (HTD2601US) | Hetaida Technology Co., Ltd. | 2024-07-01 | 62 | 0 |
| K223170 | Electronic Blood Pressure Monitor, model: HTD6602US | Hetaida Technology Co., Ltd. | 2023-12-05 | 420 | 0 |
| K203332 | Non-contact Infrared Body Thermometer, Model HTD8808C, HTD88 | Hetaida Technology Co., Ltd. | 2021-02-25 | 105 | 0 |
| K200159 | Non-contact Infrared Body Thermometer, model:HTD8823US | Hetaida Technology Co., Ltd. | 2021-01-05 | 349 | 0 |
| K180387 | Infrared Ear Thermometer | Hetaida Technology Co., Ltd. | 2019-01-10 | 332 | 0 |
| K171888 | Non-contact infrared body thermometer | Hetaida Technology Co., Ltd. | 2018-07-23 | 392 | 0 |
| K180385 | Infrared Body Thermometer | Hetaida Technology Co., Ltd. | 2018-05-11 | 88 | 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