510(k) Report

510(k) · Cleared

Cleared

Extraction Basket

K243471510(k) TraditionalCleared Dec 16, 202438-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

Micro-Tech (Nanjing) Co., Ltd. · LQR Dislodger, Stone, Biliary

Cleared on Dec 16, 2024 as substantially equivalent to K171969 (Wilson-Cook Medical, Inc., 2018) after a 38-day review. Its family tree reaches back 2 generations to 1985.

Decided
Dec 16, 2024
Review
38 days
Class
Class II
Product code
LQR
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K851965 (1985). No later device cites it as a predicate yet.

  1. Root · 2 generations backK851965 Wilson-Cook Stone ExtractorWilson-Cook Medical, Inc. · 1985
  2. 1 generation backK171969 Web II Memory Extraction Basket or Memory II Double Lumen Extraction…Wilson-Cook Medical, Inc. · 2018
  3. This deviceK243471 Extraction BasketMicro-Tech (Nanjing) Co., Ltd. · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K851965Wilson-Cook Stone ExtractorWilson-Cook Medical, Inc.1985—
−1K171969Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket…Wilson-Cook Medical, Inc.2018—
0 (this device)K243471Extraction BasketMicro-Tech (Nanjing) Co., Ltd.2024—
FIG. 1 — Lineage of K243471, 1985–2024Source: 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
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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
*K171969Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5…
Summary page 5
…es Classification: 2 Product Code: LQR Regulation Number: 21 CFR 876.5010 Review Panel: Gastroenterology/Urology 4. Identification of Predicate Device 510(k) Number: K171969 Product Name: Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket Memory 5 Fr. Soft Wire Baskets or Memor…
Wilson-Cook Medical, Inc.2018—

Also cleared against K171969: 3 other devices →

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 39 years and passes through 2 companies; a new generation was cleared every 32.7 years on median.
  • None of the 2 ancestors has a recall.
  • 3 other devices also cite its predicate K171969.

How does its category compare?

All LQR devices

LQR Dislodger, Stone, Biliary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 device is used for the endoscopic removal of stones in the biliary system and foreign bodies.

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. “K243471: Extraction Basket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243471

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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