510(k) · Cleared
ClearedEndorings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endo-Aid, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Feb 11, 2014 as substantially equivalent to K122565 (Boddingtons Plastics, Ltd., 2012) after a 103-day review. Its family tree reaches back 4 generations to 1986. 1 later device descends from it.
- Decided
- Feb 11, 2014
- Review
- 103 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K853585 (1986). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 3 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 2 generations backK984358 Olympus Distal Attachment, Models…Olympus America, Inc. · 1999 · Recalled
- 1 generation backK122565 Arc EndocuffBoddingtons Plastics, Ltd. · 2012
- This deviceK133359 EndoringsEndo-Aid, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK190030 Embrella Endoscopic Distal AttachmentMicro-Tech (Nanjing) Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190030Embrella Endoscopic Distal AttachmentMicro-Tech (Nanjing) Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −3 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −2 | K984358 | Olympus Distal Attachment, Models… | Olympus America, Inc. | 1999 | 2 |
| −1 | K122565 | Arc Endocuff | Boddingtons Plastics, Ltd. | 2012 | — |
| 0 (this device) | K133359 | Endorings | Endo-Aid, Inc. | 2014 | — |
| +1 | K190030 | Embrella Endoscopic Distal Attachment | Micro-Tech (Nanjing) Co., Ltd. | 2019 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K122565 | Arc EndocuffSummary page 1…nt Classification: Class 11 per 21 CFR 876.1500 Product Code: FED Predicate Device: Arc EndloCuff AEC 110; AEC 120; AEC 140 (K 122565) Device IDescription: The EnndoRings is a flexible silicone rubber add-on device designed to attach to the distal tip of the d… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190030 | Embrella Endoscopic Distal Attachment | 2019 | 0 |
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 28 years and passes through 4 companies; a new generation was cleared every 10.2 years on median.
- 6 of the 11 ancestors have a recall of any class.
- Of its descendants, K190030 (Micro-Tech (Nanjing) Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K122565.
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. 2014, 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?
The Endolkings is intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:
Keeping the suitable depth of endoscope's view field
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133359 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133359: Endorings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133359
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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