Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ge Medical Systems (China) Co., Ltd. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
238 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171580 | Monitor B125, Monitor B105 | Ge Medical Systems (China) Co., Ltd. | 2017-11-01 | 154 | 0 |
| K151063 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2015-12-15 | 239 | 0 |
| K142288 | MAC 800 Resting ECG Analysis System | Ge Medical Systems China Co., Ltd. | 2014-12-03 | 107 | 0 |
| K133576 | MONITOR B40 | Ge Medical Systems China Co., Ltd. | 2014-02-21 | 93 | 2 |
| K130584 | MONITOR B40 | Ge Medical Systems China Co., Ltd. | 2013-06-26 | 113 | 1 |
| K122253 | PROCARE MONITOR B20 | Ge Medical Systems China Co., Ltd. | 2013-03-22 | 238 | 1 |
| K123238 | ACHILLES | Ge Medical Systems China Co., Ltd. | 2013-02-25 | 132 | 0 |
| K120598 | PROCARE MONITOR B40 | Ge Medical Systems China Co., Ltd. | 2012-07-19 | 142 | 1 |
| K103633 | ACHILLES | Ge Medical Systems China Co., Ltd. | 2011-05-11 | 149 | 0 |
| K102256 | GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND | Ge Medical Systems China Co., Ltd. | 2010-10-05 | 56 | 0 |
| K102113 | GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND | Ge Medical Systems China Co., Ltd. | 2010-08-12 | 15 | 0 |
| K091374 | GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND | Ge Medical Systems China Co., Ltd. | 2009-05-26 | 15 | 0 |
| K091164 | GE VENUE 40, MODEL 5324338 | Ge Medical Systems China Co., Ltd. | 2009-05-05 | 13 | 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