Intromedic Co., Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Intromedic Co., Ltd.” (first 2011, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 194 days. Since 2017 the median was 262 days, against 123 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 | 2 | 232 |
| 2013 | 2 | 127 |
| 2014 | 2 | 146 |
| 2015 | 1 | 84 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 292 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 262 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Intromedic Co., Ltd. took a median 262 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | 8 | 8 |
| EOX | Esophagoscope (Flexible Or Rigid) | 3 | 3 |
Review panels
Most recent Intromedic Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252617 | MiroCam® Capsule Endoscope System | NEZ | 2026-05-08 | 262 |
| K180732 | MiroCam Capsule Endoscope System | NEZ | 2018-11-08 | 233 |
| K170438 | MiroCam Capsule Endoscope System | NEZ | 2018-01-30 | 351 |
| K143663 | MiroCam Capsule Endoscope System | NEZ | 2015-03-17 | 84 |
| K134005 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | NEZ | 2014-07-09 | 194 |
| K140751 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | NEZ | 2014-06-30 | 97 |
| K131131 | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM | EOX | 2013-06-21 | 60 |
| K123428 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | NEZ | 2013-05-20 | 194 |
| K120702 | E.G. SCAN II ESPHAGOSCOPE SYSTEM | EOX | 2012-06-20 | 104 |
| K111450 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | NEZ | 2012-05-18 | 359 |
1 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-02-15.
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 Intromedic Co., Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Intromedic Co., Ltd.” (first 2011, latest 2026), across 2 product codes in 2 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 Intromedic Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intromedic Co., Ltd. is 194 days. Since 2017: 262 days, versus 123 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Intromedic Co., Ltd.?
The most frequent FDA product codes under this applicant name are NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule, 8); EOX (Esophagoscope (Flexible Or Rigid), 3).
Next steps
- See all 11 Intromedic Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NEZ, Intromedic 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 (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.