510(k) · Cleared
ClearedClearCap Distal Attachment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Finemedix Co., Ltd. · OCX Endoscopic Irrigation/Suction System
Cleared on Feb 19, 2021 as substantially equivalent to K140315 (United States Endoscopy Group, Inc., 2014) after a 163-day review. Its family tree reaches back 1 generation to 2014. 2 later devices descend from it.
- Decided
- Feb 19, 2021
- Review
- 163 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K140315 (2014). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK140315 US Endoscopy Distal Attachment CapUnited States Endoscopy Group, Inc. · 2014
- This deviceK202616 ClearCap Distal AttachmentFinemedix Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK260423 Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK242134 ClearCap Distal AttachmentFinemedix Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K140315 | US Endoscopy Distal Attachment Cap | United States Endoscopy Group, Inc. | 2014 | — |
| 0 (this device) | K202616 | ClearCap Distal Attachment | Finemedix Co., Ltd. | 2021 | — |
| +1 | K260423 | Disposable Endoscopic Distal Attachments | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2026 | — |
| +1 | K242134 | ClearCap Distal Attachment | Finemedix Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K140315 | US Endoscopy Distal Attachment CapSummary page 4…anel: Gastroenterology/Urology • Regulation Number: 21 CFR 876.1500 • Device Class: Class II • Date Prepared: 02/18/2020 Predicate Devices: Primary Predicate K140315, US ENDOSCOPY DISTAL ATTACHMENT CAP by UNITED STATES ENDOSCOPY GROUP, INC Reference Device K162749, FUJIFILM Hood Models DH-28GR… | 2014 |
| † | K162749 | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR | 2017 |
What descends from it? (2)
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?
- Its one ancestor has no recall.
- Of its descendants, K260423 (Yangzhou Fartley Medical Instrument Technology Co., Ltd., 2026) has gone furthest, with 0 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. 2021, 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 ClearCap Distal Attachment has been designed to be attached to the distal end of the endoscope to facilitate
endoscopic therapy.
The ClearCap Distal Attachment 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 summary.
https://510kreport.com/device/K202616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202616: ClearCap Distal Attachment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202616
Report an extraction error
Are you the manufacturer?
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