510(k) Report

510(k) · Cleared

Cleared

Accordion Stone Management Device Model AC281205 and AC3814510

K102887510(k) TraditionalCleared May 16, 2011228-day reviewClass II21 CFR 876.4680

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Percutaneous Systems, Inc. · FFL Dislodger, Stone, Basket, Ureteral, Metal

Cleared on May 16, 2011 as substantially equivalent to K052048 (Percutaneous Systems, Incorporated, 2005) and 1 other predicate after a 228-day review. Its family tree reaches back 1 generation to 1987.

Decided
May 16, 2011
Review
228 days
Class
Class II
Product code
FFL
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K864874 (1987). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestorK864874 · Segura Dretler Basket · Van-Tec, Inc. · 1987198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor K864874 · Segura Dretler Basket · Van-Tec, Inc. · 19870
  1. Root · 1 generation backK864874 Segura Dretler BasketVan-Tec, Inc. · 1987
  2. This deviceK102887 Accordion Stone Management Device Model AC281205 and AC3814510Percutaneous Systems, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K864874Segura Dretler BasketVan-Tec, Inc.1987—
0 (this device)K102887Accordion Stone Management Device Model AC281205 and AC3814510Percutaneous Systems, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K102887, 1987–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K052048Accordion
Summary page 1
…teral stone dislodger 21 CFR 876.4650 Class 11 Product Code FFL Predicate Devices Accordion Stone Management Device, Percutaneous Systems, Inc. (K052048) Stone Cone, Boston Scientific Corporation (K864874) 3-1…
Percutaneous Systems, Incorporated2005—
*K864874Segura Dretler Basket
Summary page 1
…1 Product Code FFL Predicate Devices Accordion Stone Management Device, Percutaneous Systems, Inc. (K052048) Stone Cone, Boston Scientific Corporation (K864874) 3-1…
Van-Tec, Inc.1987—

Also cleared against K052048: 2 other devices →

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 devices

FFL Dislodger, Stone, Basket, Ureteral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · FFL

1in 2019

2008: 12011: 12017: 12019: 1
2007high 1 (2008) · low 0 (2007)2026

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

2008: 12014: 12022: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FFL

496in 2025

2007: 682008: 1522009: 1942010: 1922011: 1292012: 952013: 982014: 712015: 792016: 882017: 5172018: 4282019: 3512020: 3752021: 3582022: 4262023: 5932024: 6062025: 496
2007high 606 (2024) · low 68 (2007)2025

MAUDE reports naming product code FFL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—068
20081—1152
20090—0194
20100—0192
20111—0129
20120—095
20130—098
20140—171
20150—079
20160—088
20171—0517
20180—0428
20191—0351
20200—0375
20210—0358
20220—1426
20230—0593
20240—0606
20250—0496
20260—0—

What is it indicated for?

The PercSys Accordion® Stone Management Device is intended to be used in endoscopic procedures to bypass, entrap and remove calculi and other foreign objects from the urinary tract, to prevent retrograde migration of calculi during lithotripsy, and to guide instrumentation within the ureter.

Indications for use as stated in the FDA summary.

Also cleared against K052048

2 other devices cite the same predicate.

  • K172299Accordion Piccolo Stone Management DeviceThs International, Inc. D/B/A Accordion Medical · 2017
  • K113692XENXXenolith Medical · 2012

More from Percutaneous Systems, Inc.

6 FDA decisions under this applicant name. See the company

  • K082803Coaxial Accordion Stone Management Device, Model: COAC12005 - COA20015Percutaneous Systems, Inc. · 2008
  • K052134Cystoglide Dilating Introducer SheathPercutaneous Systems, Inc. · 2005
  • K042877Microverter Ureteral Access SheathPercutaneous Systems, Inc. · 2004
  • K040519Slip Urology CatheterPercutaneous Systems, Inc. · 2004
  • K040520Slip Urology Introducer SheathPercutaneous Systems, Inc. · 2004

Recent decisions in FFL

The FFL category page

  • K190492Peralta Stone Removal CatheterCalcula Technologies, Inc. · 2019
  • K172299Accordion Piccolo Stone Management DeviceThs International, Inc. D/B/A Accordion Medical · 2017
  • K082803Coaxial Accordion Stone Management Device, Model: COAC12005 - COA20015Percutaneous Systems, Inc. · 2008
  • K052048AccordionPercutaneous Systems, Incorporated · 2005
  • K012581Reprocessed Stone Retrieval BasketsSterilmed, Inc. · 20021 recall

https://510kreport.com/device/K102887 · printed Nov 4, 2026

Cite this page

510(k) Report. “K102887: Accordion Stone Management Device Model AC281205 and AC3814510.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102887

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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