# K082025: Body-Jet

- Pathway: 510(k) (Traditional)
- Applicant: Human Med AG
- Decided: Aug 13, 2008 after 27 days
- Product code: QPB (System, Suction, Lipoplasty For Removal)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K895761 (1989). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053451: Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model 00 002 252 (220 V), 00 002 318 (110 V);, Moeller Medical GmbH & Co. KG (2006) Summary page 5.
- K063336: Medela Dominant 50 Lipo, Model 600-5706, Medela AG (2007) Summary page 5.
- K981172: Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles, Byron Medical (1998) Summary page 5.

## Recalls of this device
- Oct 18, 2024 · Class II · Z-1251-2025: The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.

## Indications for use
Aesthetic body contouring

Source page: https://510kreport.com/device/K082025
Methodology: https://510kreport.com/methodology