510(k) · Cleared
Recalled · Class II · 2026NCompass Nitinol Stone Extractors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · LQR Dislodger, Stone, Biliary
Cleared on Nov 7, 2017 as substantially equivalent to K902944 (Cook, Inc., 1990) after a 41-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 7, 2017
- Review
- 41 days
- Class
- Class II
- Product code
- LQR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902944 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK902944 Wittich Nitinol Stone BasketCook, Inc. · 1990
- This deviceK173009 NCompass Nitinol Stone ExtractorsCook Incorporated · 2017
- Descendant · cites it directly · 1 of its ownK203322 SpyGlass Discover Retrieval BasketBoston Scientific Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK240192 Single-use Extraction BasketsScivita Medical Technology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK173687 Strange Bile Duct Stone Exploration SetCook Incorporated · 2017 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K203322SpyGlass Discover Retrieval BasketBoston Scientific Corporation · 2021 · cites it directly1descendant
- K240192Single-use Extraction BasketsScivita Medical Technology Co., Ltd. · 2024 · 2 generations on0descendants
- K173687Strange Bile Duct Stone Exploration SetCook Incorporated · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902944 | Wittich Nitinol Stone Basket | Cook, Inc. | 1990 | — |
| 0 (this device) | K173009 | NCompass Nitinol Stone Extractors | Cook Incorporated | 2017 | — |
| +1 | K203322 | SpyGlass Discover Retrieval Basket | Boston Scientific Corporation | 2021 | — |
| +2 | K240192 | Single-use Extraction Baskets | Scivita Medical Technology Co., Ltd. | 2024 | — |
| +1 | K173687 | Strange Bile Duct Stone Exploration Set | Cook Incorporated | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K902944 | Wittich Nitinol Stone BasketSummary page 4…21 CFR § 876.5010 Regulation Name: Biliary Catheter and Accessories Product Code: LQR Predicate Device: Wittich Nitinol Stone Basket (K902944) Device Description: The NCompass Nitinol Stone Extractor is a single-use, sterile, disposable device. The extractor is a stone… | 1990 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2026 | Class II | Z-1787-2026 | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LQR devicesLQR 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
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 NCompass Nitinol Stone Extractors are intended for extraction of stones or debris during biliary surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173009: NCompass Nitinol Stone Extractors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173009
Report an extraction error
Are you the manufacturer?
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