Shenzhen Changkun Technology Co., Ltd.: FDA clearances and approvals
Shenzhen Changkun Technology Co., Ltd. has 7 FDA 510(k) clearances (first 2020, latest 2026), across 5 product codes in 5 review panels. Median 510(k) review time: 317 days. Since 2017 its median was 317 days, against 182 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 212 |
| 2021 | 2 | 418 |
| 2022 | 0 | — |
| 2023 | 2 | 232 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 2 | 399 |
Review time against the same product codes
Since 2017, Shenzhen Changkun Technology Co., Ltd.'s cleared 510(k)s took a median 317 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 182 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| HGX | Pump, Breast, Powered | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 | 1 |
Review panels
- Cardiovascular (2)
- Obstetrics and Gynecology (2)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
- General Hospital (1)
Most recent Shenzhen Changkun Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | HGX | 2026-06-26 | 532 |
| K252552 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) | KPI | 2026-05-06 | 266 |
| K231595 | Electric Breast Pump | HGX | 2023-10-26 | 147 |
| K221798 | Finger Pulse Oximeter, Model: X1906P | DQA | 2023-05-04 | 317 |
| K193387 | Arm Electronic Sphygmomanometer | DXN | 2021-01-27 | 418 |
| K193386 | Wrist Electronic Sphygmomanometer | DXN | 2021-01-27 | 418 |
| K193253 | Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 | FLL | 2020-06-17 | 212 |
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Changkun Technology 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Shenzhen Changkun Technology Co., Ltd.'s product codes (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Frequently asked questions
How many FDA 510(k) clearances does Shenzhen Changkun Technology Co., Ltd. have?
Shenzhen Changkun Technology Co., Ltd. has 7 FDA 510(k) clearances (first 2020, latest 2026), across 5 product codes in 5 review panels.
How long does FDA take to clear Shenzhen Changkun Technology Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Shenzhen Changkun Technology Co., Ltd.'s cleared 510(k)s is 317 days. Since 2017: 317 days, versus 182 days for all cleared 510(k)s in the same product codes.
What devices does Shenzhen Changkun Technology Co., Ltd. make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); HGX (Pump, Breast, Powered, 2); DQA (Oximeter, 1).
Has Shenzhen Changkun Technology Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Shenzhen Changkun Technology Co., Ltd. Related entities may recall under other names.
Next steps
- See all 7 Shenzhen Changkun Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Shenzhen Changkun Technology 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.