510(k) · Cleared
Recalled · 2008Reprocessed Stone Retrieval Baskets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · FFL Dislodger, Stone, Basket, Ureteral, Metal
Cleared on Feb 14, 2002 as substantially equivalent to K970121 (Boston Scientific Corp, 1997) and 3 other predicates after a 189-day review. Its family tree reaches back 2 generations to 1987. It has been recalled once.
- Decided
- Feb 14, 2002
- Review
- 189 days
- Class
- Class II
- Product code
- FFL
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K871777 (1987). 7 ancestors in all, the oldest K851965 (1985). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871777 | Van-Tec Reusable Helical Stone Basket | Van-Tec, Inc. | 1987 | — |
| −1 | K970121 | Stone Dislodger, Basket | Boston Scientific Corp | 1997 | — |
| 0 (this device) | K012581 | Reprocessed Stone Retrieval Baskets | Sterilmed, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 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 FFL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K970121 | Stone Dislodger, BasketSummary page 1…s IT, 21 CFR 876.4680 FFL SterilMed’s reprocessed stone retrieval baskets are substantially equivalent to: ‘ e Boston Scientific Corporation’s Stone Dislodger Baskets (K970121, K951309, K936721) o Wilson-Cook Medical Inc.’s Stone Extractor (K851965) e The counterpart devices from the original manufacture… | 1997 |
| * | K951309 | Stone Dislodger, BasketSummary page 1…CFR 876.4680 FFL SterilMed’s reprocessed stone retrieval baskets are substantially equivalent to: ‘ e Boston Scientific Corporation’s Stone Dislodger Baskets (K970121, K951309, K936721) o Wilson-Cook Medical Inc.’s Stone Extractor (K851965) e The counterpart devices from the original manufacturers Steri… | 1995 |
| * | K935721 | Stone Extractor Our OCR of the scanned summary read K936721, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Boston Scientific Corporation’s Stone Dislodger Baskets”. | 1994 |
| * | K851965 | Wilson-Cook Stone ExtractorSummary page 1…ts are substantially equivalent to: ‘ e Boston Scientific Corporation’s Stone Dislodger Baskets (K970121, K951309, K936721) o Wilson-Cook Medical Inc.’s Stone Extractor (K851965) e The counterpart devices from the original manufacturers SterilMed’s reprocessed stone retrieval baskets consist of a handle,… | 1985 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2008 | Not classified | Z-0571-2009 | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K970121.
How does its category compare?
All FFL devicesFFL Dislodger, Stone, Basket, Ureteral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FFL
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · FFL
Too few FFL 510(k)s in any year since 2007 to give a median.
Recalls per year · FFL
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFL
496in 2025
MAUDE reports naming product code FFL, 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 | 0 | — | 0 | 68 |
| 2008 | 1 | — | 1 | 152 |
| 2009 | 0 | — | 0 | 194 |
| 2010 | 0 | — | 0 | 192 |
| 2011 | 1 | — | 0 | 129 |
| 2012 | 0 | — | 0 | 95 |
| 2013 | 0 | — | 0 | 98 |
| 2014 | 0 | — | 1 | 71 |
| 2015 | 0 | — | 0 | 79 |
| 2016 | 0 | — | 0 | 88 |
| 2017 | 1 | — | 0 | 517 |
| 2018 | 0 | — | 0 | 428 |
| 2019 | 1 | — | 0 | 351 |
| 2020 | 0 | — | 0 | 375 |
| 2021 | 0 | — | 0 | 358 |
| 2022 | 0 | — | 1 | 426 |
| 2023 | 0 | — | 0 | 593 |
| 2024 | 0 | — | 0 | 606 |
| 2025 | 0 | — | 0 | 496 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Reprocessed Stone Retrieval Baskets are used to entrap and remove renal stones and calculi via a rigid or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012581: Reprocessed Stone Retrieval Baskets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012581
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026