# K040461: Econolith E3000, Model 3000 (SW-6)

- Pathway: 510(k) (Special)
- Applicant: Medispec, Ltd.
- Decided: May 25, 2004 after 92 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 P970019 (1997). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P970019: Healthtronics Lithotron Lihtotripsy System, Healthtronics Surgical Services, Inc. (1997) Summary page 2.

## Most influential descendants
- K063504: Econolith EM1000 (2007), 6 descendants of its own
- 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

## Indications for use
The EconolithTM E3000 is indicated for use in non-invasive fragmentation of upper urinary tract stones between 5 and 20 mm in size.

Source page: https://510kreport.com/device/K040461
Methodology: https://510kreport.com/methodology