510(k) · Cleared
ClearedEndo Smartcap (100501)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endo Smart Cap Co. · OCX Endoscopic Irrigation/Suction System
Cleared on May 23, 1997 after a 57-day review. The FDA summary names its predicate without a number. 67 later devices descend from it.
- Decided
- May 23, 1997
- Review
- 57 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 0
67 later devices descend from it, 3 citing it directly.
- This deviceK971125 Endo Smartcap (100501)Endo Smart Cap Co. · 1997
- Descendant · cites it directly · 58 of its ownK031773 Endo Gator SystemByrne Medical, Inc. · 2003
- Descendant · 2 generations on · 41 of its ownK092429 EndogatorByrne Medical, Inc. · 2009
- Descendant · cites it directly · 18 of its ownK093665 Endo SmartcapByrne Medical, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 13 of its ownK091305 ClearpathEasyglide, Ltd. · 2009
- Descendant · 3 generations on · 10 of its ownK093779 Clearpath UgiEasyglide, Ltd. · 2010
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K031773Endo Gator SystemByrne Medical, Inc. · 2003 · cites it directly58descendants
- K092429EndogatorByrne Medical, Inc. · 2009 · 2 generations on41descendants
- K093665Endo SmartcapByrne Medical, Inc. · 2009 · cites it directly18descendants
- K091305ClearpathEasyglide, Ltd. · 2009 · 2 generations on13descendants
- K093779Clearpath UgiEasyglide, Ltd. · 2010 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971125 | Endo Smartcap (100501) | Endo Smart Cap Co. | 1997 | — |
| +1 | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| +2 | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| +1 | K093665 | Endo Smartcap | Byrne Medical, Inc. | 2009 | 7 |
| +2 | K091305 | Clearpath | Easyglide, Ltd. | 2009 | — |
| +3 | K093779 | Clearpath Ugi | Easyglide, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 9 | 0 |
| 2023 | 11 | 0 |
| 2024 | 7 | 0 |
| 2025 | 3 | 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 OCX? 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 OCX device
- #1 K251986 Auxiliary Water Tube Maj-855score 12.8 · 10 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 |
|---|---|---|---|
| * | — | Olympus Model Number MD-431 Water Container Named without a submission number |
What descends from it? (67)
See all 673 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, K031773 (Byrne Medical, Inc., 2003) has gone furthest, with 58 descendants of its own.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCX
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCX
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCX
33in 2025
MAUDE reports naming product code OCX, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 51 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 4 | 256 | 0 | 1 |
| 2013 | 3 | 106 | 0 | 1 |
| 2014 | 6 | 77 | 0 | 5 |
| 2015 | 2 | — | 1 | 9 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 5 | 60 | 0 | 18 |
| 2019 | 8 | 133 | 0 | 41 |
| 2020 | 4 | 88 | 11 | 11 |
| 2021 | 3 | 233 | 0 | 8 |
| 2022 | 6 | 84 | 2 | 18 |
| 2023 | 7 | 109 | 0 | 46 |
| 2024 | 4 | 74 | 0 | 21 |
| 2025 | 4 | 178 | 0 | 33 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Endo SmartCap™ is intended to supply sterile water to series 10, 100 and 130 Olympus endoscopes when connected to a commercially available sterile water bottle.
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/K971125 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971125: Endo Smartcap (100501).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971125
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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