# K111947: Duet Magna

- Pathway: 510(k) (Traditional)
- Applicant: Direx Systems Corp.
- Decided: Mar 1, 2012 after 237 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: 5 generations back to P840008 (1984). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023535: Tripter X-1 Compact Duet, Direx Systems Corp. (2003) Summary page 1.
- K041582: Modification to Tripter X-1 Compact Duet, Direx Systems Corp. (2004) Summary page 1.
- K053640: Integra, Direx Systems Corp. (2006) Summary page 1.

## Indications for use
DUET MAGNA is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter.

Source page: https://510kreport.com/device/K111947
Methodology: https://510kreport.com/methodology