510(k) · Cleared
ClearedMirocam 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 18, 2012 as substantially equivalent to K070475 (Given Imaging, Ltd., 2007) after a 359-day review. Its family tree reaches back 13 generations to 2001. 7 later devices descend from it.
- Decided
- May 18, 2012
- Review
- 359 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to DEN010002 (2001). 7 later devices descend from it, 1 citing it directly.
- Root · 13 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 9 generations between
- 3 generations backK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 2 generations backK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 1 generation backK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
- This deviceK111450 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2012
- Descendant · cites it directly · 6 of its ownK123428 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 5 of its ownK140751 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2014
- Descendant · 2 generations on · 4 of its ownK134005 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2014
- Descendant · 3 generations on · 3 of its ownK143663 MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2015
- Descendant · 4 generations on · 2 of its ownK170438 MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2018
Show all 13 generations
- Root · 13 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 12 generations backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- 11 generations backK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- 10 generations backK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 9 generations backK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 8 generations backK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 7 generations backK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
- 6 generations backK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- 5 generations backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- 4 generations backK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- 3 generations backK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 2 generations backK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 1 generation backK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
- This deviceK111450 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2012
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K123428Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2013 · cites it directly6descendants
- K140751Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2014 · 2 generations on5descendants
- K134005Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2014 · 2 generations on4descendants
- K143663MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2015 · 3 generations on3descendants
- K170438MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2018 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −12 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| −11 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| −10 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −9 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −8 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −7 | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
| −6 | K041149 | Given Diagnostic System with M2A Eso Capsule | Given Imaging, Ltd. | 2004 | — |
| −5 | K042960 | Given Diagnostic System with Pillcam Eso | Given Imaging, Ltd. | 2004 | — |
| −4 | K052184 | Given Diagnostic System | Given Imaging, Ltd. | 2005 | — |
| −3 | K060805 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −2 | K062786 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −1 | K070475 | Modificaton to: Given Diagnostic Imaging System | Given Imaging, Ltd. | 2007 | — |
| 0 (this device) | K111450 | Mirocam Capsule Endoscope System | Intromedic Co., Ltd. | 2012 | — |
| +1 | K123428 | Mirocam Capsule Endoscope System | Intromedic Co., Ltd. | 2013 | 1 |
| +2 | K140751 | Mirocam Capsule Endoscope System | Intromedic Co., Ltd. | 2014 | — |
| +2 | K134005 | Mirocam Capsule Endoscope System | Intromedic Co., Ltd. | 2014 | — |
| +3 | K143663 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2015 | — |
| +4 | K170438 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K070475 | Modificaton to: Given Diagnostic Imaging SystemSummary page 1…NEZ) 3. Predicate Device Manufacturer Given Imaging Ltd. Device Given Diagnostic Imaging System 510(K) Number K070475 4. Description The MiroCam®D Capsule Endoscope System is comprised of the following core components: - MiroCam®@ Caps… | 2007 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123428 | Mirocam Capsule Endoscope System | 2013 | 6 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K123428 (Intromedic Co., Ltd., 2013) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K070475.
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. 2012, 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 Endoscope 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/K111450 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111450: Mirocam Capsule Endoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111450
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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