# K981215: Psi-Tec Liposuction Aspirator

- Pathway: 510(k) (Traditional)
- Applicant: Byron Medical
- Decided: Jul 1, 1998 after 90 days
- Product code: QPB (System, Suction, Lipoplasty For Removal)
- Device class: 2
- Regulation: 21 CFR 878.5040
- 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 K895761 (1989). 2 ancestors in all.
26 later devices descend from it; 5 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980392: Psi-Tec Aspirator, Byron Medical (1998) Summary page 6.

## Most influential descendants
- K032802: HK Liposuction Aspirator, Model AP-Iii & AP230-Iii (2003), 22 descendants of its own
- K053451: Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model 00 002 252 (220 V), 00 002 318 (110 V); (2006), 13 descendants of its own
- K081593: Power Aspirator, Model LS2 or LS2DP (2008), 4 descendants of its own
- K063336: Medela Dominant 50 Lipo, Model 600-5706 (2007), 4 descendants of its own
- K212024: PAL System (2022), 3 descendants of its own

## Indications for use
The PSI-TEC Liposuction Aspirator(s) indications for use is for “aesthetic body contouring.

Source page: https://510kreport.com/device/K981215
Methodology: https://510kreport.com/methodology