# K063504: Econolith EM1000

- Pathway: 510(k) (Traditional)
- Applicant: Medispec, Ltd.
- Decided: Mar 9, 2007 after 109 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 P970019 (1997). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P870018: Lithostar, Siemens Corp. (1988) Summary page 2.
- P840008: Dornier Lithotripter Compact Transportable (DLCT), Dornier Medtech America, Inc. (1984) Summary page 2.
- K040461: Econolith E3000, Model 3000 (SW-6), Medispec, Ltd. (2004) Summary page 2.

## Most influential descendants
- K103217: Lite-Med LM-9200 Elma (2011), 4 descendants of its own
- K142561: LM-9300 ELMA Lithotripter (2015), 1 descendant of its own
- K072788: Storz Modulith Lithotripter SLX-F2-F180 (2007), 1 descendant of its own
- K242922: Extracorporeal Shock Wave Lithotripter (U200) (2025), 0 descendants of its own
- K201001: Modulith SLX-F2 (2021), 0 descendants of its own

## Indications for use
The EM1000 is indicated for use in the non-invasive fragmentation of upper urinary tract stones, to include urinary stones located in the kidney (renal pelvis and renal calyces) and upper ureter.

Source page: https://510kreport.com/device/K063504
Methodology: https://510kreport.com/methodology