# K062475: Lma Stonebreaker Device; Probe Size 1.0MM, 1.6MM, 2.0MM

- Pathway: 510(k) (Traditional)
- Applicant: The Laryngeal Mask Co., Ltd.
- Decided: May 9, 2007 after 258 days
- Product code: FFK (Lithotriptor, Electro-Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.4480
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K863642 (1986). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951531: Swiss Lithoclast Lithotripter, Electro Medical Systems SA (1995) Summary page 2.
- K963285: Ems Swiss Lithoclast Lithotripter, Electro Medical Systems SA (1997) Summary page 2.
- K974164: Swiss Lithoclast Master Handpiece and 3.2 MM Probe, Medical Device Consultants, Inc. (1997) Summary page 2.

## Most influential descendants
- K123038: Swiss Lithobreaker (2013), 0 descendants of its own

## Recalls of this device
- Jan 31, 2018 · Class II · Z-1593-2018: The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
- Jan 31, 2018 · Class II · Z-1592-2018: The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
- Jan 31, 2018 · Class II · Z-1594-2018: The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
- Jan 31, 2018 · Class II · Z-1595-2018: The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
- Jan 31, 2018 · Class II · Z-1596-2018: The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
- Jan 31, 2018 · Class II · Z-1590-2018: The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
- Jan 31, 2018 · Class II · Z-1591-2018: The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.

## Indications for use
The LMA StoneBreakerTM is indicated for use via a rigid or semi-rigid endoscope with a straight working channel, for the fragmentation of urinary tract (i.e. kidney, ureter and bladder) stones.

Source page: https://510kreport.com/device/K062475
Methodology: https://510kreport.com/methodology