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 Jan 30, 2018 as substantially equivalent to K143663 (Intromedic Co., Ltd., 2015) and 1 other predicate after a 351-day review. Its family tree reaches back 18 generations to 2001. 2 later devices descend from it.
- Decided
- Jan 30, 2018
- Review
- 351 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to DEN010002 (2001). 26 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 18 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 14 generations between
- 3 generations backK140751 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2014
- 2 generations backK134005 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2014
- 1 generation backK143663 MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2015
- This deviceK170438 MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK180732 MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK252617 MiroCam® Capsule Endoscope SystemIntromedic Co., Ltd. · 2026
Show all 18 generations
- Root · 18 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 17 generations backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- 16 generations backK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- 15 generations backK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 14 generations backK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 13 generations backK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 12 generations backK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
- 11 generations backK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- 10 generations backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- 9 generations backK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- 8 generations backK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 7 generations backK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 6 generations backK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
- 5 generations backK091405 Pillcam Platform with Pillcam SB Capsules with Pillcam SensorbeltGiven Imaging, Ltd. · 2009
- 4 generations backK103088 Given Pillcam Platform with Pillcam SB Capsuleswith Pillcam R…Given Imaging, Ltd. · 2011
- 3 generations backK140751 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2014
- 2 generations backK134005 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2014
- 1 generation backK143663 MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2015
- This deviceK170438 MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −17 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| −16 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| −15 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −14 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −13 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −12 | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
| −11 | K041149 | Given Diagnostic System with M2A Eso Capsule | Given Imaging, Ltd. | 2004 | — |
| −10 | K042960 | Given Diagnostic System with Pillcam Eso | Given Imaging, Ltd. | 2004 | — |
| −9 | K052184 | Given Diagnostic System | Given Imaging, Ltd. | 2005 | — |
| −8 | K060805 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −7 | K062786 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −6 | K070475 | Modificaton to: Given Diagnostic Imaging System | Given Imaging, Ltd. | 2007 | — |
| −5 | K091405 | Pillcam Platform with Pillcam SB Capsules with Pillcam Sensorbelt | Given Imaging, Ltd. | 2009 | — |
| −4 | K103088 | Given Pillcam Platform with Pillcam SB Capsuleswith Pillcam R Sensorbelt | Given Imaging, Ltd. | 2011 | — |
| −3 | K140751 | Mirocam Capsule Endoscope System | Intromedic Co., Ltd. | 2014 | — |
| −2 | K134005 | Mirocam Capsule Endoscope System | Intromedic Co., Ltd. | 2014 | — |
| −1 | K143663 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2015 | — |
| 0 (this device) | K170438 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2018 | — |
| +1 | K180732 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2018 | — |
| +2 | K252617 | MiroCam® Capsule Endoscope System | Intromedic Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K143663 | MiroCam Capsule Endoscope SystemSummary page 4…edicate Device Manufacturer IntroMedic Co., Ltd. Device MiroCam® Capsule Endoscope System 510(K) Number K143663 Manufacturer Given Imaging Ltd. Device Given PillCam SB3 Capsule endoscopy system… | 2015 |
| * | K123864 | Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy SystemSummary page 4…K143663 Manufacturer Given Imaging Ltd. Device Given PillCam SB3 Capsule endoscopy system 510(K) Number K123864 Manufacturer Given Imaging Ltd. Device Given PillCam COLON 2 Capsule endoscopy sys… | 2013 |
| † | K123666 | Given PillCam COLON 2 Capsule endoscopy system |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180732 | MiroCam Capsule Endoscope System | 2018 | 1 |
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 17 years and passes through 2 companies; a new generation was cleared every 7 months on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K180732 (Intromedic Co., Ltd., 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K143663.
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. 2018, 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?
The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. - It may be used in the visualization and monitoring of lesions that may indicate Crohn’s disease not detected by upper and lower endoscopy. - It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. - It may be used in the visualization and…
Read the full statement (143 words)
The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa.
- It may be used in the visualization and monitoring of lesions that may indicate Crohn’s disease not detected by upper and lower endoscopy.
- It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
- It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
It may be used as a tool in the detection of abnormalities of the small bowel and this device is indicated for adults only.
The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170438: MiroCam Capsule Endoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170438
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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