Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intromedic Co., Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
194 daysmedian FDA review time
351 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252617 | MiroCam® Capsule Endoscope System | Intromedic Co., Ltd. | 2026-05-08 | 262 | 0 |
| K180732 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2018-11-08 | 233 | 0 |
| K170438 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2018-01-30 | 351 | 0 |
| K143663 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2015-03-17 | 84 | 0 |
| K134005 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | Intromedic Co., Ltd. | 2014-07-09 | 194 | 0 |
| K140751 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | Intromedic Co., Ltd. | 2014-06-30 | 97 | 0 |
| K131131 | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | 2013-06-21 | 60 | 0 |
| K123428 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | Intromedic Co., Ltd. | 2013-05-20 | 194 | 0 |
| K120702 | E.G. SCAN II ESPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | 2012-06-20 | 104 | 0 |
| K111450 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | Intromedic Co., Ltd. | 2012-05-18 | 359 | 0 |
| K111030 | E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | 2011-10-21 | 191 | 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