510(k) · Cleared
ClearedAccordion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Percutaneous Systems, Incorporated · FFL Dislodger, Stone, Basket, Ureteral, Metal
Cleared on Sep 13, 2005 after a 46-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Sep 13, 2005
- Review
- 46 days
- Class
- Class II
- Product code
- FFL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK052048 AccordionPercutaneous Systems, Incorporated · 2005
- Descendant · cites it directly · 0 of its ownK172299 Accordion Piccolo Stone Management DeviceThs International, Inc. D/B/A Accordion Medical · 2017
- Descendant · cites it directly · 0 of its ownK113692 XENXXenolith Medical · 2012
- Descendant · cites it directly · 0 of its ownK102887 Accordion Stone Management Device Model AC281205 and AC3814510Percutaneous Systems, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See all- K172299Accordion Piccolo Stone Management DeviceThs International, Inc. D/B/A Accordion Medical · 2017 · cites it directly0descendants
- K113692XENXXenolith Medical · 2012 · cites it directly0descendants
- K102887Accordion Stone Management Device Model AC281205 and AC3814510Percutaneous Systems, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052048 | Accordion | Percutaneous Systems, Incorporated | 2005 | — |
| +1 | K172299 | Accordion Piccolo Stone Management Device | Ths International, Inc. D/B/A Accordion Medical | 2017 | — |
| +1 | K113692 | XENX | Xenolith Medical | 2012 | — |
| +1 | K102887 | Accordion Stone Management Device Model AC281205 and AC3814510 | Percutaneous Systems, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 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? (3)
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 |
|---|---|---|---|
| * | — | SLIP Urology Introducer Sheath Named without a submission number | |
| * | — | Stone Cone Nitinol Urological Retrieval Coil Named without a submission number | |
| * | — | Movable Core Guidewire Named without a submission number |
What descends from it? (3)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K172299 (Ths International, Inc. D/B/A Accordion Medical, 2017) has gone furthest, with 0 descendants of its own.
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?
The ACCORDION Urological Occluding Guidewire 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/K052048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052048: Accordion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052048
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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