510(k) · Cleared
ClearedSpyGlass Discover Retrieval Basket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · LQR Dislodger, Stone, Biliary
Cleared on May 26, 2021 as substantially equivalent to K173009 (Cook Incorporated, 2017) after a 195-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- May 26, 2021
- Review
- 195 days
- Class
- Class II
- Product code
- LQR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902944 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK902944 Wittich Nitinol Stone BasketCook, Inc. · 1990
- 1 generation backK173009 NCompass Nitinol Stone ExtractorsCook Incorporated · 2017 · Recalled
- This deviceK203322 SpyGlass Discover Retrieval BasketBoston Scientific Corporation · 2021
- Descendant · cites it directly · 0 of its ownK240192 Single-use Extraction BasketsScivita Medical Technology Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240192Single-use Extraction BasketsScivita Medical Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902944 | Wittich Nitinol Stone Basket | Cook, Inc. | 1990 | — |
| −1 | K173009 | NCompass Nitinol Stone Extractors | Cook Incorporated | 2017 | 1 |
| 0 (this device) | K203322 | SpyGlass Discover Retrieval Basket | Boston Scientific Corporation | 2021 | — |
| +1 | K240192 | Single-use Extraction Baskets | Scivita Medical Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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 K253056 Disposable Stone Extraction Basketscore 11.7 · 3 generations · 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 |
|---|---|---|---|
| * | K173009 | NCompass Nitinol Stone ExtractorsSummary page 5…age 2 of 3 3. Predicate Device: Trade Name: Cook NCompass Nitinol Stone Extractor 510(k) Number: K173009 Device Common Name: Dislodger, Stone, Biliary Regulation Name: Bilia… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240192 | Single-use Extraction Baskets | 2024 | 0 |
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 31 years and passes through 3 companies; a new generation was cleared every 27.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K240192 (Scivita Medical Technology Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K173009.
How does its category compare?
All LQR devicesLQR Dislodger, Stone, Biliary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LQR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LQR
248in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LQR
3in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LQR
111in 2025
MAUDE reports naming product code LQR, 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 | 1 | — | 0 | 23 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 2 | — | 3 | 28 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 0 | 47 |
| 2012 | 0 | — | 0 | 50 |
| 2013 | 1 | — | 0 | 13 |
| 2014 | 0 | — | 0 | 21 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 4 | 148 | 0 | 11 |
| 2018 | 3 | 248 | 0 | 43 |
| 2019 | 1 | — | 0 | 41 |
| 2020 | 1 | — | 0 | 51 |
| 2021 | 1 | — | 0 | 47 |
| 2022 | 0 | — | 0 | 58 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 2 | — | 0 | 69 |
| 2025 | 1 | — | 0 | 111 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SpyGlass Discover Retrieval Basket is indicated for the endoscopic removal of stones and stone fragments in the biliary system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203322: SpyGlass Discover Retrieval Basket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203322
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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