# K010309: Sonopet Model Ust-2001 Ultrasonic Surgical Aspirator

- Pathway: 510(k) (Traditional)
- Applicant: Mutoh America Co., Ltd.
- Decided: Apr 18, 2001 after 76 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 5 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021989: Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3 (2002), 23 descendants of its own
- K071669: Integra Selector Ultrasonic Surgical Aspirator System with Bone Tip (2007), 17 descendants of its own
- K042277: Selector Quantum Ultrasonic Aspirator System (2004), 17 descendants of its own
- K081459: Cusa Selector NXT Ultrasonic Tissue Ablation System (2008), 16 descendants of its own
- K161882: CUSA Clarity Ultrasonic Surgical Aspirator System (2016), 11 descendants of its own

## Recalls of this device
- Jun 24, 2014 · Class II · Z-2156-2014: The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.
- Jun 24, 2013 · Class II · Z-1878-2013: A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the cor
- Jun 24, 2013 · Class II · Z-1880-2013: A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the cor
- Jun 24, 2013 · Class II · Z-1879-2013: A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the cor

Source page: https://510kreport.com/device/K010309
Methodology: https://510kreport.com/methodology