# K032424: LOTUS

- Pathway: 510(k) (Traditional)
- Applicant: Sra Developments, Ltd.
- Decided: Dec 16, 2003 after 133 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- 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 K925699 (1993). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980099: Ultracision  Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5)), Ethicon Endo-Surgery, Inc. (1998) Summary page 1.
- K971861: Ultrasonic Hand Instruments, United States Surgical, A Division of Tyco Healthc (1997) Summary page 1.

## Most influential descendants
- K063531: Series 3 Lotus Laparoscopic Ultrasound Surgery System (2007), 2 descendants of its own
- K151101: Lotus Series 4 Ultrasonic Surgical System & Accessories (2015), 1 descendant of its own
- K221102: LOTUS Series 4 Enhanced Shears, LOTUS Series 5 (2022), 0 descendants of its own

## Indications for use
The LOTUS Laproscopic Ultrasound Surgery System is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. LOTUS may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecologic, and thoracic surgery.

Source page: https://510kreport.com/device/K032424
Methodology: https://510kreport.com/methodology