510(k) · Cleared
Recalled · Class III · 2016Roth Net Retriever
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Endoscopy Group, Inc. · FDI Snare, Flexible
Cleared on Sep 11, 2012 as substantially equivalent to K926104 (United States Endoscopy Group, Inc., 1993) after a 29-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 11, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- FDI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926104 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK926104 Polyp NetUnited States Endoscopy Group, Inc. · 1993
- This deviceK122462 Roth Net RetrieverUnited States Endoscopy Group, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK152580 rescuenetEndochoice, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK142258 PolyCatch Retrieval DeviceMedi-Globe Corporation · 2014
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 | K926104 | Polyp Net | United States Endoscopy Group, Inc. | 1993 | — |
| 0 (this device) | K122462 | Roth Net Retriever | United States Endoscopy Group, Inc. | 2012 | — |
| +1 | K152580 | rescuenet | Endochoice, Inc. | 2015 | — |
| +1 | K142258 | PolyCatch Retrieval Device | Medi-Globe Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 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 FDI? 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 FDI device
- #1 K251692 Advanced Tissue Resection Devicescore 10.9 · 1 generation · 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 |
|---|---|---|---|
| * | K926104 | Polyp NetSummary page 1…cessories. Predicate Device Information The predicate device is the US Endoscopy Polyp Snare Net (AKA, the Roth Nete retriever), cleared under 510(k) K926104 aon April 5, 1993. Labeling and Intended Use Since introduction of the Polyp Snare Net in 1993,… | 1993 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 13, 2016 | Class III | Z-1416-2017 | Labeling mix-ups | The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K152580 (Endochoice, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FDI devicesFDI Snare, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FDI
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FDI
247in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDI
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDI
274in 2025
MAUDE reports naming product code FDI, 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 | 48 |
| 2008 | 2 | — | 0 | 201 |
| 2009 | 1 | — | 0 | 265 |
| 2010 | 0 | — | 1 | 174 |
| 2011 | 1 | — | 0 | 177 |
| 2012 | 1 | — | 0 | 162 |
| 2013 | 3 | 87 | 0 | 191 |
| 2014 | 5 | 47 | 0 | 345 |
| 2015 | 3 | 62 | 1 | 195 |
| 2016 | 1 | — | 0 | 223 |
| 2017 | 1 | — | 0 | 154 |
| 2018 | 4 | 214 | 0 | 181 |
| 2019 | 3 | 100 | 0 | 135 |
| 2020 | 2 | — | 0 | 487 |
| 2021 | 1 | — | 0 | 211 |
| 2022 | 4 | 247 | 0 | 246 |
| 2023 | 1 | — | 0 | 209 |
| 2024 | 0 | — | 0 | 279 |
| 2025 | 0 | — | 2 | 274 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Roth Net® retriever product line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
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/K122462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122462: Roth Net Retriever.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122462
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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