510(k) Report

510(k) · Cleared

Cleared

rescuenet

K152580510(k) TraditionalCleared Nov 3, 201554-day reviewClass II21 CFR 876.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Endochoice, Inc. · FDI Snare, Flexible

Cleared on Nov 3, 2015 as substantially equivalent to K122462 (United States Endoscopy Group, Inc., 2012) after a 54-day review. Its family tree reaches back 2 generations to 1993.

Decided
Nov 3, 2015
Review
54 days
Class
Class II
Product code
FDI
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K926104 (1993). No later device cites it as a predicate yet.

  1. Root · 2 generations backK926104 Polyp NetUnited States Endoscopy Group, Inc. · 1993
  2. 1 generation backK122462 Roth Net RetrieverUnited States Endoscopy Group, Inc. · 2012 · Recalled
  3. This deviceK152580 rescuenetEndochoice, Inc. · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K926104Polyp NetUnited States Endoscopy Group, Inc.1993—
−1K122462Roth Net RetrieverUnited States Endoscopy Group, Inc.20121
0 (this device)K152580rescuenetEndochoice, Inc.2015—
FIG. 1 — Lineage of K152580, 1993–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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. #1 K251692 Advanced Tissue Resection Devicescore 10.9 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K122462Roth Net Retriever
Summary page 5
…t. 7.2 Intended Use The indications for use of the EndoChoice retrieval net is substantially equivalent to the predicate device, the Roth Net® retrieval product line (K122462) manufactured United States Endoscopy Group, Inc. In each case, the nets are intended for use in endoscopic retrieval of objects.…
United States Endoscopy Group, Inc.20121

Also cleared against K122462: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 22 years and passes through 2 companies; a new generation was cleared every 19.4 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • 1 other device also cites its predicate K122462.

How does its category compare?

All FDI devices

FDI Snare, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · FDI

1in 2023

2008: 22009: 12011: 12012: 12013: 32014: 52015: 32016: 12017: 12018: 42019: 32020: 22021: 12022: 42023: 12026 (partial year): 1
2007high 5 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDI

247in 2022

2013: 87 days median2014: 47 days median2015: 62 days median2018: 214 days median2019: 100 days median2022: 247 days median
2007high 247 (2022) · low 47 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FDI

2in 2025

2010: 12015: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FDI

274in 2025

2007: 482008: 2012009: 2652010: 1742011: 1772012: 1622013: 1912014: 3452015: 1952016: 2232017: 1542018: 1812019: 1352020: 4872021: 2112022: 2462023: 2092024: 2792025: 274
2007high 487 (2020) · low 48 (2007)2025

MAUDE reports naming product code FDI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—048
20082—0201
20091—0265
20100—1174
20111—0177
20121—0162
20133870191
20145470345
20153621195
20161—0223
20171—0154
201842140181
201931000135
20202—0487
20211—0211
202242470246
20231—0209
20240—0279
20250—2274
20261—0—

What is it indicated for?

The retrieval net is intended for use in endoscopic retrieval of foreign objects, food bolus, tissue fragments and excised tissue such as polyps.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K152580: rescuenet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152580

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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