Qingdao Hisense Medical Equipment Co., Ltd.: FDA clearances and approvals
Qingdao Hisense Medical Equipment Co., Ltd. has 9 FDA 510(k) clearances (first 2015, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time: 112 days. Since 2017 its median was 122 days, against 97 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 2 | 40 |
| 2016 | 1 | 24 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 4 | 114 |
| 2023 | 0 | — |
| 2024 | 2 | 146 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Qingdao Hisense Medical Equipment Co., Ltd.'s cleared 510(k)s took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 97 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | 5 | 5 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 3 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
- Radiology (9)
Most recent Qingdao Hisense Medical Equipment Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233841 | HD80 Series Ultrasound Diagnostic System | IYN | 2024-05-16 | 164 |
| K233439 | HD60 Series Ultrasound Diagnostic System | IYN | 2024-02-21 | 128 |
| K222208 | Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D | PGY | 2022-11-17 | 115 |
| K222132 | Hisense LCD monitor HMD2G21S, HMD3G21S | PGY | 2022-11-08 | 112 |
| K221567 | LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) | PGY | 2022-07-26 | 56 |
| K213862 | HD60 Series Ultrasound Diagnostic System | IYN | 2022-06-08 | 180 |
| K160347 | Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 | PGY | 2016-03-03 | 24 |
| K152030 | Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) | PGY | 2015-09-16 | 56 |
| K151709 | Hi-Light Diagnostic Ultrasound Systems | IYO | 2015-07-17 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Qingdao Hisense Medical Equipment 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 Qingdao Hisense Medical Equipment Co., Ltd. have?
Qingdao Hisense Medical Equipment Co., Ltd. has 9 FDA 510(k) clearances (first 2015, latest 2024), across 3 product codes in 1 review panel.
How long does FDA take to clear Qingdao Hisense Medical Equipment Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Qingdao Hisense Medical Equipment Co., Ltd.'s cleared 510(k)s is 112 days. Since 2017: 122 days, versus 97 days for all cleared 510(k)s in the same product codes.
What devices does Qingdao Hisense Medical Equipment Co., Ltd. make?
Its most frequent FDA product codes are PGY (Display, Diagnostic Radiology, 5); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 3); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1).
Has Qingdao Hisense Medical Equipment Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Qingdao Hisense Medical Equipment Co., Ltd. Related entities may recall under other names.
Next steps
- See all 9 Qingdao Hisense Medical Equipment Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code PGY, Qingdao Hisense Medical Equipment 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.