510(k) · Cleared
ClearedPeralta Stone Removal Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Calcula Technologies, Inc. · FFL Dislodger, Stone, Basket, Ureteral, Metal
Cleared on Jul 18, 2019 as substantially equivalent to K831875 (Vpi, 1983) and 1 other predicate after a 140-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Jul 18, 2019
- Review
- 140 days
- Class
- Class II
- Product code
- FFL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K831875 (1983). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK831875 Balloon Dilation Helical Stone ExtractVpi · 1983
- This deviceK190492 Peralta Stone Removal CatheterCalcula Technologies, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831875 | Balloon Dilation Helical Stone Extract | Vpi | 1983 | — |
| 0 (this device) | K190492 | Peralta Stone Removal Catheter | Calcula Technologies, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (2)
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 |
|---|---|---|---|
| * | K831875 | Balloon Dilation Helical Stone ExtractSummary page 4…l Catheter is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K831875 Balloon Dilation Helical Stone Extractor / VPI K941853 Passport / Boston Scientific Corp… | 1983 |
| * | K941853 | PassportSummary page 4…te Device Name / Manufacturer Primary Predicate K831875 Balloon Dilation Helical Stone Extractor / VPI K941853 Passport / Boston Scientific Corp Zero Tip Nitinol Stone Retrieval Basket / Boston Scientific Reference… | 1994 |
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?
- None of the 2 ancestors has a recall.
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. 2019, this device’s year, is highlighted.
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?
The Peralta Stone Removal Catheter is intended to be used endoscopically to grasp, manipulate, and remove calculi from the urinary tract, and/or for ureteral dilation.
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/K190492 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190492: Peralta Stone Removal Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190492
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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