510(k) · Cleared
ClearedArc Endocuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boddingtons Plastics, Ltd. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Sep 4, 2012 as substantially equivalent to K984358 (Olympus America, Inc., 1999) and 1 other predicate after a 13-day review. Its family tree reaches back 3 generations to 1986. 4 later devices descend from it.
- Decided
- Sep 4, 2012
- Review
- 13 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K853585 (1986). 10 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 2 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 1 generation backK984358 Olympus Distal Attachment, Models…Olympus America, Inc. · 1999 · Recalled
- This deviceK122565 Arc EndocuffBoddingtons Plastics, Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK133359 EndoringsEndo-Aid, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK190030 Embrella Endoscopic Distal AttachmentMicro-Tech (Nanjing) Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK162205 Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK160846 AmplifEYEMedivators, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K133359EndoringsEndo-Aid, Inc. · 2014 · cites it directly1descendant
- K190030Embrella Endoscopic Distal AttachmentMicro-Tech (Nanjing) Co., Ltd. · 2019 · 2 generations on0descendants
- K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd. · 2016 · cites it directly0descendants
- K160846AmplifEYEMedivators, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −2 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −1 | K984358 | Olympus Distal Attachment, Models… | Olympus America, Inc. | 1999 | 2 |
| 0 (this device) | K122565 | Arc Endocuff | Boddingtons Plastics, Ltd. | 2012 | — |
| +1 | K133359 | Endorings | Endo-Aid, Inc. | 2014 | — |
| +2 | K190030 | Embrella Endoscopic Distal Attachment | Micro-Tech (Nanjing) Co., Ltd. | 2019 | — |
| +1 | K162205 | Arc EndoCuff and Arc EndoCuff Vision | Boddingtons Plastics, Ltd. | 2016 | — |
| +1 | K160846 | AmplifEYE | Medivators, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 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 FED? 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 FED device
- #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K984358 | Olympus Distal Attachment, Models…Summary page 1…__________ Arc EndloCuff MN-Series D-201 BS-2 Balloon (K984358) (K984358) (K090116) Model No. AEC 110 MH-463 D-20… | 1999 |
| * | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Summary page 1…MN-Series D-201 BS-2 Balloon (K984358) (K984358) (K090116) Model No. AEC 110 MH-463 D-201-13404 BS-2 Balloon Model No. AEC 120… | 2009 |
What descends from it? (4)
3 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?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 6 of the 10 ancestors have a recall of any class.
- Of its descendants, K133359 (Endo-Aid, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K984358.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, 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 | 1 | — | 1 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 0 | — |
What is it indicated for?
To be attached to the distal end of the endloscope to facilitate endloscopic therapy, to be used for the following:
* Keeping the suitable depth of endloscope's view field
* Helping the endloscope with being inserted into the gastrointestinal tract
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122565: Arc Endocuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122565
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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