Ge Medical Systems China Co., Ltd.: FDA clearances and approvals
Ge Medical Systems China Co., Ltd. has 12 FDA 510(k) clearances (first 2009, latest 2015), across 5 product codes in 2 review panels. Median 510(k) review time: 110 days. openFDA lists 27 product recalls by a recalling firm named Ge Medical Systems China Co., Ltd.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 142 |
| 2013 | 3 | 132 |
| 2014 | 2 | 100 |
| 2015 | 1 | 239 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 5 | 5 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 3 | 3 |
| MUA | Bone Sonometer | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
- Cardiovascular (6)
- Radiology (6)
Most recent Ge Medical Systems China Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151063 | Monitor B40 | MHX | 2015-12-15 | 239 |
| K142288 | MAC 800 Resting ECG Analysis System | DPS | 2014-12-03 | 107 |
| K133576 | MONITOR B40 | MHX | 2014-02-21 | 93 |
| K130584 | MONITOR B40 | MHX | 2013-06-26 | 113 |
| K122253 | PROCARE MONITOR B20 | MHX | 2013-03-22 | 238 |
| K123238 | ACHILLES | MUA | 2013-02-25 | 132 |
| K120598 | PROCARE MONITOR B40 | MHX | 2012-07-19 | 142 |
| K103633 | ACHILLES | MUA | 2011-05-11 | 149 |
| K102256 | GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND | IYN | 2010-10-05 | 56 |
| K102113 | GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND | IYN | 2010-08-12 | 15 |
2 earlier clearances. See the full list in Caduvo.
Recalls
27 product recalls in 7 recall events; 22 initiated in the last five years. Most recent: 2026-04-21.
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 Ge Medical Systems China Co., Ltd. have?
Ge Medical Systems China Co., Ltd. has 12 FDA 510(k) clearances (first 2009, latest 2015), across 5 product codes in 2 review panels.
How long does FDA take to clear Ge Medical Systems China Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Ge Medical Systems China Co., Ltd.'s cleared 510(k)s is 110 days.
What devices does Ge Medical Systems China Co., Ltd. make?
Its most frequent FDA product codes are MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 5); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 3); MUA (Bone Sonometer, 2).
Has Ge Medical Systems China Co., Ltd. had device recalls?
openFDA lists 27 product recalls in 7 recall events by a recalling firm whose name matches Ge Medical Systems China Co., Ltd; the most recent began 2026-04-21. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 12 Ge Medical Systems China Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MHX, Ge Medical Systems China 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.