Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Samsung Electronics Co., Ltd. — Predicate Candidate Screening
42 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
224 days90th percentile
42clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261187 | Hearing Aid Feature | Samsung Electronics Co., Ltd. | 2026-07-31 | 112 | 0 |
| K261011 | Sleep Apnea Feature (v2.0) | Samsung Electronics Co., Ltd. | 2026-07-20 | 116 | 0 |
| K242651 | GM85 | Samsung Electronics Co., Ltd. | 2024-10-01 | 27 | 0 |
| K242478 | GF85 (models GF85-3P, GF85-SP) | Samsung Electronics Co., Ltd. | 2024-09-19 | 29 | 0 |
| K240909 | Samsung ECG App v 1.3 (ECG) | Samsung Electronics Co., Ltd. | 2024-08-02 | 122 | 0 |
| DEN230041 | Sleep Apnea Feature | Samsung Electronics Co., Ltd. | 2024-02-06 | 251 | 0 |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm | Samsung Electronics Co., Ltd. | 2023-05-02 | 89 | 0 |
| K222353 | GM85 | Samsung Electronics Co., Ltd. | 2022-09-29 | 56 | 3 |
| K213452 | GEMS-H | Samsung Electronics Co., Ltd. | 2022-04-21 | 177 | 0 |
| K220175 | GM85 | Samsung Electronics Co., Ltd. | 2022-04-21 | 90 | 0 |
| K211139 | CUBE Air Purifier | Samsung Electronics Co., Ltd. | 2021-11-26 | 224 | 0 |
| K201560 | Auto Lung Nodule Detection | Samsung Electronics Co., Ltd. | 2021-08-31 | 447 | 0 |
| K201168 | ECG Monitor App | Samsung Electronics Co., Ltd. | 2020-08-04 | 95 | 0 |
| K182183 | GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A | Samsung Electronics Co., Ltd. | 2018-12-07 | 116 | 0 |
| K182647 | GC70 | Samsung Electronics Co., Ltd. | 2018-10-24 | 30 | 0 |
| K182622 | GU60A, GU60A-65 | Samsung Electronics Co., Ltd. | 2018-10-23 | 29 | 0 |
| K181631 | GR40CW | Samsung Electronics Co., Ltd. | 2018-07-20 | 30 | 0 |
| K181626 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2018-07-20 | 30 | 0 |
| K181629 | GC85A | Samsung Electronics Co., Ltd. | 2018-07-20 | 30 | 0 |
| K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | Samsung Electronics Co., Ltd. | 2018-05-24 | 84 | 0 |
| K173828 | GU60A & GU60A-65 | Samsung Electronics Co., Ltd. | 2018-01-12 | 25 | 0 |
| K172229 | GC85A | Samsung Electronics Co., Ltd. | 2017-11-22 | 120 | 0 |
| K171119 | GM85 | Samsung Electronics Co., Ltd. | 2017-05-12 | 28 | 0 |
| K163115 | GC70 | Samsung Electronics Co., Ltd. | 2016-12-07 | 30 | 0 |
| K162278 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2016-11-15 | 92 | 0 |
| K160997 | GC85A | Samsung Electronics Co., Ltd. | 2016-07-06 | 86 | 0 |
| K153401 | GR40CW | Samsung Electronics Co., Ltd. | 2015-12-21 | 27 | 0 |
| K152094 | GR40CW | Samsung Electronics Co., Ltd. | 2015-10-16 | 80 | 0 |
| K151685 | GUA60A, GU60A-65 | Samsung Electronics Co., Ltd. | 2015-07-17 | 25 | 0 |
| K151419 | GF50A | Samsung Electronics Co., Ltd. | 2015-06-23 | 26 | 0 |
| K150165 | GC85A | Samsung Electronics Co., Ltd. | 2015-04-02 | 66 | 0 |
| K150097 | GM60A-32S & GM60A-40S | Samsung Electronics Co., Ltd. | 2015-02-19 | 30 | 2 |
| K143029 | Digital Diagnostic X-ray System (GC80) | Samsung Electronics Co., Ltd. | 2015-02-04 | 106 | 0 |
| K142492 | GM60A-32S, GM60A-40S | Samsung Electronics Co., Ltd. | 2014-12-17 | 104 | 1 |
| K140326 | XGEO GF50 | Samsung Electronics Co., Ltd. | 2014-05-29 | 108 | 0 |
| K140332 | XGEO GU60A | Samsung Electronics Co., Ltd. | 2014-05-28 | 107 | 0 |
| K140334 | XGEO GC80 | Samsung Electronics Co., Ltd. | 2014-05-28 | 107 | 0 |
| K140235 | XGEO GR40CW | Samsung Electronics Co., Ltd. | 2014-05-15 | 105 | 0 |
| K132148 | S HEALTH | Samsung Electronics Co., Ltd. | 2013-12-04 | 146 | 0 |
| K123106 | DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A | Samsung Electronics Co., Ltd. | 2013-06-20 | 261 | 0 |
| K123105 | XGEO GU60 | Samsung Electronics Co., Ltd. | 2013-06-07 | 248 | 0 |
| K123098 | XGEO GC80 | Samsung Electronics Co., Ltd. | 2013-01-18 | 108 | 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