510(k) Report

510(k) · Cleared

Cleared

Single Use Retrieval Nitinol Basket V

K170811510(k) TraditionalCleared Nov 27, 2017255-day reviewClass II21 CFR 876.5010

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

Olympus Medical Systems Corp. · LQR Dislodger, Stone, Biliary

Cleared on Nov 27, 2017 as substantially equivalent to K040447 (Boston Scientific Corp, 2004) and 1 other predicate after a 255-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it.

Decided
Nov 27, 2017
Review
255 days
Class
Class II
Product code
LQR
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K925495 (1992). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1994: 1 other ancestor2025: 1 descendant clearedK925495 · Microvasive Insurg Helical & Mini-Helical Baskets · Boston Scientific Corp · 1992K964937 · A Lithotripter-Compatible Basket · Boston Scientific Corp · 1997K040447 · Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088 · Boston Scientific Corp · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 1 descendant K040447 · Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088 · Boston Scientific Corp · 2004K964937 · A Lithotripter-Compatible Basket · Boston Scientific Corp · 1997K925495 · Microvasive Insurg Helical & Mini-Helical Baskets · Boston Scientific Corp · 19920
  1. Root · 3 generations backK925495 Microvasive Insurg Helical & Mini-Helical BasketsBoston Scientific Corp · 1992
  2. 2 generations backK964937 A Lithotripter-Compatible BasketBoston Scientific Corp · 1997
  3. 1 generation backK040447 Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088Boston Scientific Corp · 2004
  4. This deviceK170811 Single Use Retrieval Nitinol Basket VOlympus Medical Systems Corp. · 2017
  5. Descendant · cites it directly · 0 of its ownK243807 Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp. · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K243807Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K925495Microvasive Insurg Helical & Mini-Helical BasketsBoston Scientific Corp1992—
−2K964937A Lithotripter-Compatible BasketBoston Scientific Corp1997—
−1K040447Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088Boston Scientific Corp2004—
0 (this device)K170811Single Use Retrieval Nitinol Basket VOlympus Medical Systems Corp.2017—
+1K243807Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K170811, 1992–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 LQR? 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 LQR device

  1. #1 K253056 Disposable Stone Extraction Basketscore 11.7 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K040447Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088
Summary page 5
…number TRAPEZOID RX Retrieval Basket / BOSTON SCIENTIFIC K040447 LITHOTRIPTER Lithotripsy CORP. COMPATIBLE Basket BASKET, MODELS 1086, 1087, 1088 Olympus Basket…
Boston Scientific Corp2004—
*K955063Olympus Basket Graspers
Summary page 5
…ipsy CORP. COMPATIBLE Basket BASKET, MODELS 1086, 1087, 1088 Olympus Basket Grasping forceps OLYMPUS AMERICA INC. K955063 Graspers 5.4 Device Description The subject device is designed to be used with Olympus endoscopes to retrieve stones from t…
Olympus America, Inc.1996—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K243807Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp.20250

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 25 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K243807 (Olympus Medical Systems Corp., 2025) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LQR devices

LQR Dislodger, Stone, Biliary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · LQR

1in 2025

2007: 12009: 22013: 12017: 42018: 32019: 12020: 12021: 12023: 12024: 22025: 12026 (partial year): 1
2007high 4 (2017) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LQR

248in 2018

2017: 148 days median2018: 248 days median
2007high 248 (2018) · low 148 (2017)2026

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

Recalls per year · LQR

3in 2009

2009: 3
2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · LQR

111in 2025

2007: 232008: 42009: 282010: 392011: 472012: 502013: 132014: 212015: 122016: 42017: 112018: 432019: 412020: 512021: 472022: 582023: 712024: 692025: 111
2007high 111 (2025) · low 4 (2008)2025

MAUDE reports naming product code LQR, 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
20071—023
20080—04
20092—328
20100—039
20110—047
20120—050
20131—013
20140—021
20150—012
20160—04
20174148011
20183248043
20191—041
20201—051
20211—047
20220—058
20231—071
20242—069
20251—0111
20261—0—

What is it indicated for?

This instrument has been designed to be used with Olympus endoscopes to retrieve stones from the biliary tract.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K170811: Single Use Retrieval Nitinol Basket V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170811

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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