510(k) Report

510(k) · Cleared

Cleared

Wittich Nitinol Stone Basket

K902944510(k) TraditionalCleared Sep 12, 199069-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

Cook, Inc. · LQR Dislodger, Stone, Biliary

Cleared on Sep 12, 1990 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided
Sep 12, 1990
Review
69 days
Class
Class II
Product code
LQR
Recalls
None
Predicates
0

7 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2009: 1 descendant cleared2017: 3 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK902944 Wittich Nitinol Stone BasketCook, Inc. · 1990
  2. Descendant · cites it directly · 3 of its ownK173009 NCompass Nitinol Stone ExtractorsCook Incorporated · 2017 · Recalled
  3. Descendant · 2 generations on · 1 of its ownK203322 SpyGlass Discover Retrieval BasketBoston Scientific Corporation · 2021
  4. Descendant · 3 generations on · 0 of its ownK240192 Single-use Extraction BasketsScivita Medical Technology Co., Ltd. · 2024
  5. Descendant · cites it directly · 0 of its ownK171915 Nathanson Transcystic Bile Duct Stone Exploration PackCook Incorporated · 2018
  6. Descendant · 2 generations on · 0 of its ownK173687 Strange Bile Duct Stone Exploration SetCook Incorporated · 2017 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2009: 12017: 32018: 12021: 12024: 1
2009high 3 (2017) · low 0 (2010)2026

Most influential descendants

Showing 5 of 7 · See all
  • K173009NCompass Nitinol Stone ExtractorsCook Incorporated · 2017 · cites it directly3descendants
  • K203322SpyGlass Discover Retrieval BasketBoston Scientific Corporation · 2021 · 2 generations on1descendant
  • K240192Single-use Extraction BasketsScivita Medical Technology Co., Ltd. · 2024 · 3 generations on0descendants
  • K171915Nathanson Transcystic Bile Duct Stone Exploration PackCook Incorporated · 2018 · cites it directly0descendants
  • K173687Strange Bile Duct Stone Exploration SetCook Incorporated · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K902944Wittich Nitinol Stone BasketCook, Inc.1990—
+1K173009NCompass Nitinol Stone ExtractorsCook Incorporated20171
+2K203322SpyGlass Discover Retrieval BasketBoston Scientific Corporation2021—
+3K240192Single-use Extraction BasketsScivita Medical Technology Co., Ltd.2024—
+1K171915Nathanson Transcystic Bile Duct Stone Exploration PackCook Incorporated2018—
+2K173687Strange Bile Duct Stone Exploration SetCook Incorporated20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201730
201810
202110
202410
FIG. 1 — Lineage of K902944, 1990–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (7)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K173009NCompass Nitinol Stone ExtractorsCook Incorporated20173
K171915Nathanson Transcystic Bile Duct Stone Exploration PackCook Incorporated20180
K170898Wittich Nitinol Stone BasketCook Incorporated20170
K082735Stone Grasping Basket, Model PD-T1 2115Sialo Technology, Ltd.20090

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?

  • Of its descendants, K173009 (Cook Incorporated, 2017) has gone furthest, with 3 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.

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—
Cite this page

510(k) Report. “K902944: Wittich Nitinol Stone Basket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K902944

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026