510(k) · Cleared
ClearedOlympus Small Intestinal Capsule Endoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Cleared on Mar 5, 2019 as substantially equivalent to K173459 (Olympus Medical Systems Corp., 2018) after a 123-day review. Its family tree reaches back 5 generations to 2009.
- Decided
- Mar 5, 2019
- Review
- 123 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K090210 (2009). No later device cites it as a predicate yet.
- Root · 5 generations backK090210 Modification to Olympus Capsule Endoscope SystemOlympus Medical Systems Corporation · 2009
- 4 generations backK123421 Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp. · 2013
- 3 generations backK142680 Endocapsule Software 10; Endocapsule Software 10 LightOlympus Medical Systems Corp. · 2015
- 2 generations backK163069 Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp. · 2017
- 1 generation backK173459 Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp. · 2018
- This deviceK183053 Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K090210 | Modification to Olympus Capsule Endoscope System | Olympus Medical Systems Corporation | 2009 | — |
| −4 | K123421 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | 2013 | — |
| −3 | K142680 | Endocapsule Software 10; Endocapsule Software 10 Light | Olympus Medical Systems Corp. | 2015 | — |
| −2 | 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 | — |
| 0 (this device) | K183053 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | 2019 | — |
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 |
|---|---|---|---|
| * | K173459 | Olympus Small Intestinal Capsule Endoscope SystemSummary page 5…) Submitter 510(k) No. OLYMPUS SMALL INTESTINAL OLYMPUS MEDICAL K173459 CAPSULE ENDOSCOPE SYSTEM SYSTEMS CORP. 5.4 DEVICE DESCRIPTION General Description of the subject device The… | 2018 |
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 10 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 5 ancestors has a recall.
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. 2019, 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 SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine 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…
Read the full statement (153 words)
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine 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.
The Red Lesion Detector is intended to mark frames of the video suspected of containing active bleeding, bleeding, angioectasia, red spot, ulcer or erosion.
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM may be used as a tool in the detection of abnormalities of the small intestine and is intended for use in adults only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183053 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183053: Olympus Small Intestinal 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/K183053
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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