# K213772: LM-9300 Plus Lithotripter

- Pathway: 510(k) (Traditional)
- Applicant: Lite-Med, Inc.
- Decided: Jan 19, 2023 after 413 days
- Product code: LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5990
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011700 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120769: Modulth SLK, KARL STORZ Endoscopy-America, Inc. (2012) Summary page 4.

## Indications for use
The Lite-Med LM-9300 Plus Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper ureteral stones by extracorporeal shock wave lithotripsy (ESWL).

Source page: https://510kreport.com/device/K213772
Methodology: https://510kreport.com/methodology