Samsung Electronics Co., Ltd.: FDA filings under this applicant name
FDA lists 42 510(k) clearances under the applicant name “Samsung Electronics Co., Ltd.” (first 2013, latest 2026), plus 1 De Novo decision, across 10 product codes in 6 review panels. Median 510(k) review time under this name: 91 days. Since 2017 the median was 89 days, against 87 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 4 | 197 |
| 2014 | 5 | 107 |
| 2015 | 7 | 30 |
| 2016 | 3 | 86 |
| 2017 | 2 | 74 |
| 2018 | 8 | 30 |
| 2019 | 0 | — |
| 2020 | 1 | 95 |
| 2021 | 2 | 336 |
| 2022 | 3 | 90 |
| 2023 | 1 | 89 |
| 2024 | 3 | 29 |
| 2025 | 0 | — |
| 2026 | 3 | 116 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Samsung Electronics Co., Ltd. took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 87 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | 21 | 21 |
| IZL | System, X-Ray, Mobile | 8 | 8 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 4 | 4 |
| QDA | Electrocardiograph Software For Over-The-Counter Use | 3 | 3 |
| QZW | Over-The-Counter Device To Assess Risk Of Sleep Apnea | 2 | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
| FRA | Purifier, Air, Ultraviolet, Medical | 1 | 1 |
| MYN | Analyzer, Medical Image | 1 | 1 |
| PHL | Powered Exoskeleton | 1 | 1 |
| SCR | Air-Conduction Hearing Aid Software | 1 | 1 |
Review panels
- Radiology (34)
- Cardiovascular (4)
- Anesthesiology (2)
- Ear, Nose and Throat (1)
- General Hospital (1)
- Neurology (1)
Most recent Samsung Electronics Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260481 | GC85A | KPR | 2026-08-27 | 195 |
| K261187 | Hearing Aid Feature | SCR | 2026-07-31 | 112 |
| K261011 | Sleep Apnea Feature (v2.0) | QZW | 2026-07-20 | 116 |
| K242651 | GM85 | IZL | 2024-10-01 | 27 |
| K242478 | GF85 (models GF85-3P, GF85-SP) | KPR | 2024-09-19 | 29 |
| K240909 | Samsung ECG App v 1.3 (ECG) | QDA | 2024-08-02 | 122 |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | QDA | 2023-05-02 | 89 |
| K222353 | GM85 | IZL | 2022-09-29 | 56 |
| K220175 | GM85 | IZL | 2022-04-21 | 90 |
| K213452 | GEMS-H | PHL | 2022-04-21 | 177 |
32 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230041 | De Novo | Over-The-Counter Device To Assess Risk Of Sleep Apnea | 2024-02-06 |
Recalls
openFDA lists no recalls under a recalling firm named Samsung Electronics Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Samsung Electronics Co., Ltd. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03962517: Effect of GEMS-H on Locomotor Function in Adults (Completed, started 2019-05-28)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Samsung Medison Co., Ltd. (73 510(k)s)
- Samsung Sds Co., Ltd. (6 510(k)s)
- Samsung Mobile Display Co., Ltd. (5 510(k)s)
- Samsung Strategy and Innovation Center (Ssic) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Samsung Electronics Co., Ltd.?
FDA lists 42 510(k) clearances under the applicant name “Samsung Electronics Co., Ltd.” (first 2013, latest 2026), plus 1 De Novo decision, across 10 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Samsung Electronics Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Samsung Electronics Co., Ltd. is 91 days. Since 2017: 89 days, versus 87 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Samsung Electronics Co., Ltd.?
The most frequent FDA product codes under this applicant name are KPR (System, X-Ray, Stationary, 21); IZL (System, X-Ray, Mobile, 8); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 4).
Next steps
- See all 42 Samsung Electronics Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KPR, Samsung Electronics Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.