DRGEM Corporation: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “DRGEM Corporation” (first 2010, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 83 days. Since 2017 the median was 61 days, against 117 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 5 | 61 |
| 2020 | 3 | 22 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 57 |
| 2024 | 1 | 159 |
| 2025 | 2 | 143 |
| 2026 | 1 | 122 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name DRGEM Corporation took a median 61 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | 7 | 7 |
| IZL | System, X-Ray, Mobile | 6 | 6 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (14)
Most recent DRGEM Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO) | IZL | 2026-05-14 | 122 |
| K251443 | PROMO | IZL | 2025-08-22 | 105 |
| K242019 | GXR-Series Diagnostic X-Ray System | KPR | 2025-01-07 | 181 |
| K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | IZL | 2024-12-16 | 159 |
| K232178 | GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) | KPR | 2023-09-19 | 57 |
| K202572 | GXR-Series Diagnostic X-Ray System | KPR | 2020-09-24 | 20 |
| K202156 | DIAMOND-5A/6A/8A | KPR | 2020-09-10 | 45 |
| K201124 | TOPAZ Mobile DR System | IZL | 2020-05-19 | 22 |
| K192453 | DIAMOND-5A/6A/8A | KPR | 2019-10-01 | 22 |
| K192364 | GXR-Series Diagnostic X-Ray System | KPR | 2019-09-26 | 27 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named DRGEM Corporation.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under DRGEM Corporation?
FDA lists 14 510(k) clearances under the applicant name “DRGEM Corporation” (first 2010, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by DRGEM Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name DRGEM Corporation is 83 days. Since 2017: 61 days, versus 117 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under DRGEM Corporation?
The most frequent FDA product codes under this applicant name are KPR (System, X-Ray, Stationary, 7); IZL (System, X-Ray, Mobile, 6); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 14 DRGEM Corporation clearances with predicates and recalls
- Run predicate analysis for product code KPR, DRGEM Corporation'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.