Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CHISON Medical Technologies Co., Ltd. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
225 daysmedian FDA review time
245 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253949 | SonoPort Series Digital Color Doppler Ultrasound System (Son | CHISON Medical Technologies Co., Ltd. | 2026-05-22 | 163 | 0 |
| K233697 | SonoMax Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | 2024-08-09 | 266 | 0 |
| K223570 | SonoAir Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | 2023-03-31 | 122 | 0 |
| K202457 | M1 Surgical Face Mask | CHISON Medical Technologies Co., Ltd. | 2021-04-29 | 245 | 0 |
| K201965 | SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye | CHISON Medical Technologies Co., Ltd. | 2021-03-02 | 230 | 0 |
| K201968 | SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Pa | CHISON Medical Technologies Co., Ltd. | 2021-02-26 | 226 | 0 |
| K201967 | SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Pal | CHISON Medical Technologies Co., Ltd. | 2021-02-26 | 226 | 0 |
| K201971 | SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Pal | CHISON Medical Technologies Co., Ltd. | 2021-02-25 | 225 | 0 |
| K201969 | SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Pal | CHISON Medical Technologies Co., Ltd. | 2021-02-25 | 225 | 0 |
| K200780 | XBit Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | 2020-08-05 | 133 | 0 |
| K180974 | CBit Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | 2018-08-17 | 126 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda