Honsun (Nantong) Co., Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Honsun (Nantong) Co., Ltd.” (first 2009, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 162 days. Since 2017 the median was 207 days, against 180 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 62 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 253 |
| 2018 | 1 | 335 |
| 2019 | 0 | — |
| 2020 | 1 | 207 |
| 2021 | 1 | 195 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 119 |
| 2026 | 3 | 90 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Honsun (Nantong) Co., Ltd. took a median 207 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 180 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 9 | 9 |
| DXQ | Blood Pressure Cuff | 2 | 2 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Review panels
- Cardiovascular (11)
- Anesthesiology (1)
- General Hospital (1)
Most recent Honsun (Nantong) Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262658 | Automatic Digital Blood Pressure monitor (LD-526) | DXN | 2026-08-31 | 32 |
| K252399 | Portable Oxygen Concentrator | CAW | 2026-06-17 | 321 |
| K260260 | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) | DXN | 2026-04-28 | 90 |
| K251795 | Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) | DXN | 2025-10-09 | 119 |
| K211629 | Infrared forehead thermometer LD-FT-100B | FLL | 2021-12-08 | 195 |
| K192500 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer | DXQ | 2020-04-06 | 207 |
| K170866 | Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 | DXN | 2018-02-21 | 335 |
| K170466 | Automatic Blood Pressure Monitor Model LD-518 & LD-537 | DXN | 2017-10-27 | 254 |
| K170454 | Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U | DXN | 2017-10-25 | 252 |
| K132627 | AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | DXN | 2013-10-23 | 62 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Honsun (Nantong) 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 Honsun (Nantong) Co., Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Honsun (Nantong) Co., Ltd.” (first 2009, latest 2026), across 4 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 Honsun (Nantong) Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Honsun (Nantong) Co., Ltd. is 162 days. Since 2017: 207 days, versus 180 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Honsun (Nantong) Co., Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 9); DXQ (Blood Pressure Cuff, 2); CAW (Generator, Oxygen, Portable, 1).
Next steps
- See all 13 Honsun (Nantong) Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Honsun (Nantong) 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.