CHISON Medical Technologies Co., Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “CHISON Medical Technologies Co., Ltd.” (first 2018, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 225 days. Since 2017 the median was 225 days, against 113 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 | 1 | 126 |
| 2019 | 0 | — |
| 2020 | 1 | 133 |
| 2021 | 6 | 226 |
| 2022 | 0 | — |
| 2023 | 1 | 122 |
| 2024 | 1 | 266 |
| 2025 | 0 | — |
| 2026 | 1 | 163 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name CHISON Medical Technologies Co., Ltd. took a median 225 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 10 | 10 |
| FXX | Mask, Surgical | 1 | 1 |
Review panels
- Radiology (10)
- General Hospital (1)
Most recent CHISON Medical Technologies Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253949 | SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 | IYN | 2026-05-22 | 163 |
| K233697 | SonoMax Series Digital Color Doppler Ultrasound System | IYN | 2024-08-09 | 266 |
| K223570 | SonoAir Series Digital Color Doppler Ultrasound System | IYN | 2023-03-31 | 122 |
| K202457 | M1 Surgical Face Mask | FXX | 2021-04-29 | 245 |
| K201965 | SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System | IYN | 2021-03-02 | 230 |
| K201968 | SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System | IYN | 2021-02-26 | 226 |
| K201967 | SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System | IYN | 2021-02-26 | 226 |
| K201971 | SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System | IYN | 2021-02-25 | 225 |
| K201969 | SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System | IYN | 2021-02-25 | 225 |
| K200780 | XBit Series Digital Color Doppler Ultrasound System | IYN | 2020-08-05 | 133 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named CHISON Medical Technologies 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Chison Medical Imaging Co., Ltd. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under CHISON Medical Technologies Co., Ltd.?
FDA lists 11 510(k) clearances under the applicant name “CHISON Medical Technologies Co., Ltd.” (first 2018, latest 2026), across 2 product codes in 2 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 CHISON Medical Technologies Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name CHISON Medical Technologies Co., Ltd. is 225 days. Since 2017: 225 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under CHISON Medical Technologies Co., Ltd.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 10); FXX (Mask, Surgical, 1).
Next steps
- See all 11 CHISON Medical Technologies Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYN, CHISON Medical Technologies 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.