510(k) · Cleared
ClearedOlympus Capsule Endoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Cleared on Sep 14, 2007 as substantially equivalent to DEN010002 (Given Imaging, Ltd., 2001) and 5 other predicates after a 319-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- Sep 14, 2007
- Review
- 319 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to DEN010002 (2001). No later device cites it as a predicate yet.
- Root · 11 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 7 generations between
- 3 generations backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- 2 generations backK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- 1 generation backK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- This deviceK063259 Olympus Capsule Endoscope SystemOlympus Medical Systems Corporation · 2007
Show all 11 generations
- Root · 11 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 10 generations backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- 9 generations backK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- 8 generations backK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 7 generations backK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 6 generations backK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 5 generations backK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
- 4 generations backK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- 3 generations backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- 2 generations backK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- 1 generation backK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- This deviceK063259 Olympus Capsule Endoscope SystemOlympus Medical Systems Corporation · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −10 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| −9 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| −8 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −7 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −6 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −5 | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
| −4 | K041149 | Given Diagnostic System with M2A Eso Capsule | Given Imaging, Ltd. | 2004 | — |
| −3 | K042960 | Given Diagnostic System with Pillcam Eso | Given Imaging, Ltd. | 2004 | — |
| −2 | K052184 | Given Diagnostic System | Given Imaging, Ltd. | 2005 | — |
| −1 | K060805 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| 0 (this device) | K063259 | Olympus Capsule Endoscope System | Olympus Medical Systems Corporation | 2007 | — |
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? (6)
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 |
|---|---|---|---|
| * | DEN010002 | Given Diagnostic Imaging System Our reading of the summary gave K010312, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN010002, Given Diagnostic Imaging System (Given Imaging, Ltd.), granted Aug 1, 2001; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2001 |
| * | K020341 | Given Diagnostic System | 2002 |
| * | K022362 | Given Diagnostics SystemSummary page 2…K010312 Gie®Dansicmgn ytm GvnIaigLtd 2 1<02034 1 Given® Diagnostic System Giv~en mgngLd 3 K022362 Given® Diagnostic System Given Imaging Ltd. 4 K(022980 Given® Diagnosti yse… | 2002 |
| * | K022980 | Modification to Given Diagnostic SystemSummary page 2…Given® Diagnostic System Giv~en mgngLd 3 K022362 Given® Diagnostic System Given Imaging Ltd. 4 K(022980 Given® Diagnosti yse Given Imaging Ltd. 5 K(031033 Given® Diagnostic System… | 2003 |
| * | K031033 | Given Diagnostic SystemSummary page 2…iven® Diagnostic System Given Imaging Ltd. 4 K(022980 Given® Diagnosti yse Given Imaging Ltd. 5 K(031033 Given® Diagnostic System Given Imaging Ltd. 6 K060805 Given® Diagnostic System… | 2003 |
| * | K060805 | Modification to Given Diagnostic SystemSummary page 2…Given® Diagnosti yse Given Imaging Ltd. 5 K(031033 Given® Diagnostic System Given Imaging Ltd. 6 K060805 Given® Diagnostic System Given Imaging Ltd. Section 3 Device Description The OLYMPUS CAPSULE ENDOSCOP… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- None of the 11 ancestors has a recall.
- 12 other devices also cite its predicate DEN010002.
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. 2007, 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 OLYMPUS CAPSULE ENDOSCOPE SYSTEM has been designed to be used for visualization of the small intestine mucosa, The Red Color Detection Function 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/K063259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063259: Olympus 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/K063259
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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