510(k) · Cleared
ClearedAccordion Piccolo Stone Management Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ths International, Inc. D/B/A Accordion Medical · FFL Dislodger, Stone, Basket, Ureteral, Metal
Cleared on Sep 19, 2017 as substantially equivalent to K052048 (Percutaneous Systems, Incorporated, 2005) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Sep 19, 2017
- Review
- 50 days
- Class
- Class II
- Product code
- FFL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K052048 (2005). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK052048 AccordionPercutaneous Systems, Incorporated · 2005
- This deviceK172299 Accordion Piccolo Stone Management DeviceThs International, Inc. D/B/A Accordion Medical · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052048 | Accordion | Percutaneous Systems, Incorporated | 2005 | — |
| 0 (this device) | K172299 | Accordion Piccolo Stone Management Device | Ths International, Inc. D/B/A Accordion Medical | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K052048 | AccordionSummary page 4…FFL Device Class: 2 Predicate Devices/ Substantial Equivalence Accordion Stone Management Device (PA 1205-06-10) (K052048) Accordion CoAx Stone Control Device (PA 1305-01-10, PA 1305-01-15) (K082803) Intended Use/Indications f… | 2005 |
| * | K082803 | Coaxial Accordion Stone Management Device, Model: COAC12005 - COA20015Summary page 4…ivalence Accordion Stone Management Device (PA 1205-06-10) (K052048) Accordion CoAx Stone Control Device (PA 1305-01-10, PA 1305-01-15) (K082803) Intended Use/Indications for Use The Accordion Piccolo Stone Management Device is intended to be used endoscopically to entrap… | 2008 |
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.
- 2 other devices also cite its predicate K052048.
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. 2017, 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 Accordion Piccolo Stone Management Device is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172299: Accordion Piccolo Stone Management Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172299
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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