Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Qingdao Hisense Medical Equipment Co., Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
180 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233841 | HD80 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co., Ltd. | 2024-05-16 | 164 | 0 |
| K233439 | HD60 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co., Ltd. | 2024-02-21 | 128 | 0 |
| K222208 | Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D | Qingdao Hisense Medical Equipment Co., Ltd. | 2022-11-17 | 115 | 0 |
| K222132 | Hisense LCD monitor HMD2G21S, HMD3G21S | Qingdao Hisense Medical Equipment Co., Ltd. | 2022-11-08 | 112 | 0 |
| K221567 | LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) | Qingdao Hisense Medical Equipment Co., Ltd. | 2022-07-26 | 56 | 0 |
| K213862 | HD60 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co., Ltd. | 2022-06-08 | 180 | 0 |
| K160347 | Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 | Qingdao Hisense Medical Equipment Co., Ltd. | 2016-03-03 | 24 | 0 |
| K152030 | Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) | Qingdao Hisense Medical Equipment Co., Ltd. | 2015-09-16 | 56 | 0 |
| K151709 | Hi-Light Diagnostic Ultrasound Systems | Qingdao Hisense Medical Equipment Co., Ltd. | 2015-07-17 | 23 | 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