# K101482: EM-9000

- Pathway: 510(k) (Traditional)
- Applicant: Elite Medical, Inc.
- Decided: Mar 31, 2011 after 307 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: 1 generation back to P840008 (1984). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040476: Storz Modulith, Model SLX-F2, KARL STORZ Endoscopy-America, Inc. (2004) Summary page 1.
- K070799: Modularis Variostar, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- P840008: Dornier Lithotripter Compact Transportable (DLCT), Dornier Medtech America, Inc. (1984) Summary page 1.

## Most influential descendants
- K251562: OTSCneo System Set (100.03n-14n, 100.27n-31n) (2025), 0 descendants of its own
- K131721: Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1 (2014), 0 descendants of its own

## Indications for use
The EM-9000 Lithotripsy system is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

Source page: https://510kreport.com/device/K101482
Methodology: https://510kreport.com/methodology