Honsun (Nantong) Co., Ltd.: FDA clearances and approvals
Honsun (Nantong) Co., Ltd. has 13 FDA 510(k) clearances (first 2009, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time: 162 days. Since 2017 its median was 207 days, against 180 days for all cleared 510(k)s in the same product codes.
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, Honsun (Nantong) Co., Ltd.'s cleared 510(k)s 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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Honsun (Nantong) Co., Ltd. have?
Honsun (Nantong) Co., Ltd. has 13 FDA 510(k) clearances (first 2009, latest 2026), across 4 product codes in 3 review panels.
How long does FDA take to clear Honsun (Nantong) Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Honsun (Nantong) Co., Ltd.'s cleared 510(k)s is 162 days. Since 2017: 207 days, versus 180 days for all cleared 510(k)s in the same product codes.
What devices does Honsun (Nantong) Co., Ltd. make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 9); DXQ (Blood Pressure Cuff, 2); CAW (Generator, Oxygen, Portable, 1).
Has Honsun (Nantong) Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Honsun (Nantong) Co., Ltd. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.