Hetaida Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Hetaida Technology Co., Ltd.” (first 2018, latest 2025), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 218 days. Since 2017 the median was 218 days, against 176 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 2 | 240 |
| 2019 | 1 | 332 |
| 2020 | 0 | — |
| 2021 | 2 | 227 |
| 2022 | 0 | — |
| 2023 | 1 | 420 |
| 2024 | 1 | 62 |
| 2025 | 1 | 72 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hetaida Technology Co., Ltd. took a median 218 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 176 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 5 | 5 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
Review panels
Most recent Hetaida Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243661 | Electronic Blood Pressure Monitor | DXN | 2025-02-07 | 72 |
| K241202 | Electric nasal aspirator (HTD2601US) | BTA | 2024-07-01 | 62 |
| K223170 | Electronic Blood Pressure Monitor, model: HTD6602US | DXN | 2023-12-05 | 420 |
| K203332 | Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C | FLL | 2021-02-25 | 105 |
| K200159 | Non-contact Infrared Body Thermometer, model:HTD8823US | FLL | 2021-01-05 | 349 |
| K180387 | Infrared Ear Thermometer | FLL | 2019-01-10 | 332 |
| K171888 | Non-contact infrared body thermometer | FLL | 2018-07-23 | 392 |
| K180385 | Infrared Body Thermometer | FLL | 2018-05-11 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Hetaida Technology 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 Hetaida Technology Co., Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Hetaida Technology Co., Ltd.” (first 2018, latest 2025), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hetaida Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hetaida Technology Co., Ltd. is 218 days. Since 2017: 218 days, versus 176 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hetaida Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 5); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1).
Next steps
- See all 8 Hetaida Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Hetaida Technology 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.