# K040149: Psi-Tec Peristaltic Infiltration Pump

- Pathway: 510(k) (Traditional)
- Applicant: Byron Medical
- Decided: Jun 3, 2004 after 132 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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 K991437 (1999). 2 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012044: BI-Phasic Infiltrator, Reliance Medical Corp. (2001) Summary page 2.
- K991437: Wells Johnson Infusion System, Model 20-6000-00, Wells Johnson Co. (1999) Summary page 2.

## Cited in the summary but kept off the family tree
- K980394: Autofuse V Infiltration Pump. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- K092066: Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste Collection Kit (Was-01), Phaser Cannulae (2010), 2 descendants of its own
- K121218: Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3 Aperture Reusable Cannula, 4MM Dia, (2012), 1 descendant of its own
- K130152: Hydrasolve Lipoplasty System (2013), 0 descendants of its own
- K101413: Euromi Eva SP6 (2010), 0 descendants of its own
- K071588: Dispenser DP 20 (2007), 0 descendants of its own

## Indications for use
The PSI TEC III Peristaltic Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The PSI TEC III Peristaltic Infiltration Pump is not intended for intravenous use.

Source page: https://510kreport.com/device/K040149
Methodology: https://510kreport.com/methodology