Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ge Hualun Medical Systems Co. , Ltd. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
167 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253269 | OEC One CFD | Ge Hualun Medical Systems Co. , Ltd. | 2025-11-26 | 58 | 0 |
| K250788 | Definium Tempo Select | Ge Hualun Medical Systems Co. , Ltd. | 2025-08-28 | 167 | 0 |
| K240828 | OEC One ASD | Ge Hualun Medical Systems Co. , Ltd. | 2024-12-27 | 276 | 0 |
| K242678 | Definium Pace Select ET | Ge Hualun Medical Systems Co. , Ltd. | 2024-10-01 | 25 | 0 |
| K231892 | Definium Pace Select | Ge Hualun Medical Systems Co. , Ltd. | 2023-09-12 | 76 | 1 |
| K191699 | Discovery XR656 HD with VolumeRad | Ge Hualun Medical Systems Co. , Ltd. | 2019-07-24 | 29 | 3 |
| K182626 | OEC One | Ge Hualun Medical Systems Co. , Ltd. | 2018-11-16 | 53 | 0 |
| K173612 | Optima XR646 HD | Ge Hualun Medical Systems Co. , Ltd. | 2017-12-11 | 19 | 1 |
| K172700 | OEC One | Ge Hualun Medical Systems Co. , Ltd. | 2017-11-09 | 63 | 0 |
| K172869 | Discovery XR656 HD | Ge Hualun Medical Systems Co. , Ltd. | 2017-10-20 | 30 | 1 |
| K171800 | OEC Elite MiniView | Ge Hualun Medical Systems Co. , Ltd. | 2017-07-12 | 26 | 0 |
| K143270 | Optima XR646 | Ge Hualun Medical Systems Co. , Ltd. | 2015-02-18 | 97 | 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