# K980392: Psi-Tec Aspirator

- Pathway: 510(k) (Traditional)
- Applicant: Byron Medical
- Decided: Mar 5, 1998 after 31 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895761 (1989). 1 ancestor in all.
27 later devices descend from it; 3 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)
- K895761: General Asperator, Kolster Methods (1989) Summary page 2.
- (no number) Grams Aspirator: named in the summary without a submission number
- (no number) Aspirator and Aspirator II: named in the summary without a submission number
- (no number) General Aspirator: named in the summary without a submission number

## Most influential descendants
- K981215: Psi-Tec Liposuction Aspirator (1998), 26 descendants of its own
- 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

## Indications for use
The PSI-TEC Aspirator(s) indications for use are general surgical fluids, exudate, soft tissue, and general tissue removal from surgical sites.

Source page: https://510kreport.com/device/K980392
Methodology: https://510kreport.com/methodology