# K262200: Stone Clear (BWSC-LP9-02)

- Pathway: 510(k) (Special)
- Applicant: Sonomotion, Inc.
- Decided: Jul 29, 2026 after 30 days
- Product code: QNA (Ultrasonic Urinary Stone Propulsion Device)
- Device class: 2
- Regulation: 21 CFR 876.4690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230082 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230082: Stone Clear (SC-LP9-01), Sonomotion, Inc. (2024) Summary page 5.

## Indications for use
The Stone Clear ultrasonic propulsion device is indicated for the repositioning of residual stone fragments post-lithotripsy that are located in the upper urinary tract of adult patients to facilitate passage, where any individual fragment is less than or equal to 5 mm.

Source page: https://510kreport.com/device/K262200
Methodology: https://510kreport.com/methodology