510(k) · Cleared
ClearedUS Endoscopy Distal Attachment Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Endoscopy Group, Inc. · OCX Endoscopic Irrigation/Suction System
Cleared on Apr 4, 2014 after a 53-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Apr 4, 2014
- Review
- 53 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK140315 US Endoscopy Distal Attachment CapUnited States Endoscopy Group, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK202616 ClearCap Distal AttachmentFinemedix Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK260423 Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK242134 ClearCap Distal AttachmentFinemedix Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K202616ClearCap Distal AttachmentFinemedix Co., Ltd. · 2021 · cites it directly2descendants
- K260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K242134ClearCap Distal AttachmentFinemedix Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K140315 | US Endoscopy Distal Attachment Cap | United States Endoscopy Group, Inc. | 2014 | — |
| +1 | K202616 | ClearCap Distal Attachment | Finemedix Co., Ltd. | 2021 | — |
| +2 | K260423 | Disposable Endoscopic Distal Attachments | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2026 | — |
| +2 | K242134 | ClearCap Distal Attachment | Finemedix Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202616 | ClearCap Distal Attachment | 2021 | 2 |
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, K202616 (Finemedix Co., Ltd., 2021) has gone furthest, with 2 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. 2014, this device’s year, is highlighted.
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 US Endoscopy Distal Attachment Cap has been designed to be attached to the distal end of the endoscope to facilitate endoscopic therapy.
The US Endoscopy Distal Attachment Cap is intended for the following.
• Gastrointestinal mucosal resection (endoscopic mucosal resection)
• Keeping the suitable depth of the endoscope's view field
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K140315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140315: US Endoscopy Distal Attachment Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140315
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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