510(k) · Cleared
Recalled · Class II · 2017Mirocam Capsule Endoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intromedic Co., Ltd. · NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Cleared on May 20, 2013 as substantially equivalent to K111450 (Intromedic Co., Ltd., 2012) after a 194-day review. Its family tree reaches back 14 generations to 2001. 6 later devices descend from it. It has been recalled once.
- Decided
- May 20, 2013
- Review
- 194 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 14 generations to DEN010002 (2001). 6 later devices descend from it, 2 citing it directly.
- Root · 14 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 10 generations between
- 3 generations backK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 2 generations backK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
- 1 generation backK111450 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2012
- This deviceK123428 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2013
- Descendant · cites it directly · 5 of its ownK140751 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2014
- Descendant · cites it directly · 4 of its ownK134005 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2014
- Descendant · 2 generations on · 3 of its ownK143663 MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2015
- Descendant · 3 generations on · 2 of its ownK170438 MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK180732 MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2018
Show all 14 generations
- Root · 14 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 13 generations backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- 12 generations backK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- 11 generations backK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 10 generations backK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 9 generations backK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 8 generations backK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
- 7 generations backK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- 6 generations backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- 5 generations backK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- 4 generations backK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 3 generations backK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 2 generations backK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
- 1 generation backK111450 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2012
- This deviceK123428 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K140751Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2014 · cites it directly5descendants
- K134005Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2014 · cites it directly4descendants
- K143663MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2015 · 2 generations on3descendants
- K170438MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2018 · 3 generations on2descendants
- K180732MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −13 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| −12 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| −11 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −10 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −9 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −8 | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
| −7 | K041149 | Given Diagnostic System with M2A Eso Capsule | Given Imaging, Ltd. | 2004 | — |
| −6 | K042960 | Given Diagnostic System with Pillcam Eso | Given Imaging, Ltd. | 2004 | — |
| −5 | K052184 | Given Diagnostic System | Given Imaging, Ltd. | 2005 | — |
| −4 | K060805 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −3 | K062786 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −2 | K070475 | Modificaton to: Given Diagnostic Imaging System | Given Imaging, Ltd. | 2007 | — |
| −1 | K111450 | Mirocam Capsule Endoscope System | Intromedic Co., Ltd. | 2012 | — |
| 0 (this device) | K123428 | Mirocam Capsule Endoscope System | Intromedic Co., Ltd. | 2013 | — |
| +1 | K140751 | Mirocam Capsule Endoscope System | Intromedic Co., Ltd. | 2014 | — |
| +1 | K134005 | Mirocam Capsule Endoscope System | Intromedic Co., Ltd. | 2014 | — |
| +2 | K143663 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2015 | — |
| +3 | K170438 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2018 | — |
| +3 | K180732 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NEZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NEZ device
- #1 K252617 MiroCam® Capsule Endoscope Systemscore 17.0 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111450 | Mirocam Capsule Endoscope SystemSummary page 1…3. Predicate Device Manufacturer IntroMedic Co., Ltd. Device MiroCam®g Capsule Endloscope System 510(K) Number K1 11450 4. Description The MiroCam® Capsule Endloscope System is comprised of the following core components: - MiroCam® Capsu… | 2012 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 15, 2017 | Class II | Z-1615-2018 | Device Design | When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery voltage. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 7 months on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K140751 (Intromedic Co., Ltd., 2014) has gone furthest, with 5 descendants of its own.
How does its category compare?
All NEZ devicesNEZ System, Imaging, Gastrointestinal, Wireless, Capsule: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NEZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEZ
99in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEZ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEZ
69in 2025
MAUDE reports naming product code NEZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 13 |
| 2011 | 3 | 213 | 1 | 10 |
| 2012 | 1 | — | 0 | 19 |
| 2013 | 3 | 194 | 0 | 6 |
| 2014 | 3 | 194 | 0 | 13 |
| 2015 | 2 | — | 0 | 30 |
| 2016 | 2 | — | 0 | 57 |
| 2017 | 4 | 83 | 0 | 55 |
| 2018 | 3 | 233 | 0 | 50 |
| 2019 | 2 | — | 0 | 56 |
| 2020 | 1 | — | 0 | 31 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 1 | — | 0 | 63 |
| 2023 | 1 | — | 0 | 34 |
| 2024 | 3 | 99 | 0 | 103 |
| 2025 | 1 | — | 0 | 69 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
MiroCam® Capsule Endloscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.
The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123428 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123428: Mirocam Capsule Endoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123428
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026