510(k) · Cleared
ClearedModification to Olympus 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 Jul 29, 2009 after a 182-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 29, 2009
- Review
- 182 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK090210 Modification to Olympus Capsule Endoscope SystemOlympus Medical Systems Corporation · 2009
- Descendant · cites it directly · 4 of its ownK123421 Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp. · 2013
- Descendant · 2 generations on · 3 of its ownK142680 Endocapsule Software 10; Endocapsule Software 10 LightOlympus Medical Systems Corp. · 2015
- Descendant · 3 generations on · 2 of its ownK163069 Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp. · 2017
- Descendant · cites it directly · 1 of its ownK173459 Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp. · 2018
- Descendant · 2 generations on · 0 of its ownK183053 Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp. · 2019
Most influential descendants
Showing 5 of 5 · See all- K123421Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp. · 2013 · cites it directly4descendants
- K142680Endocapsule Software 10; Endocapsule Software 10 LightOlympus Medical Systems Corp. · 2015 · 2 generations on3descendants
- K163069Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp. · 2017 · 3 generations on2descendants
- K173459Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp. · 2018 · cites it directly1descendant
- K183053Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090210 | Modification to Olympus Capsule Endoscope System | Olympus Medical Systems Corporation | 2009 | — |
| +1 | K123421 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | 2013 | — |
| +2 | K142680 | Endocapsule Software 10; Endocapsule Software 10 Light | Olympus Medical Systems Corp. | 2015 | — |
| +3 | K163069 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | 2017 | — |
| +1 | K173459 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | 2018 | — |
| +2 | K183053 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K123421 (Olympus Medical Systems Corp., 2013) has gone furthest, with 4 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. 2009, 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 | — |
https://510kreport.com/device/K090210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090210: Modification to 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/K090210
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026