# K980738: Psi-Tec Syringe Infusion Pump and Accessories for General Fluid Irrigaion/Infiltration

- Pathway: 510(k) (Traditional)
- Applicant: Byron Medical
- Decided: Jun 16, 1998 after 111 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: 2 generations back to K800560 (1980). 6 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K820937: Ackrad Fluid Connecting Set, Ackrad Laboratories (1982) Summary page 2.
- K973133: Big Bag 3000 Pressure Infusor, Byron Medical (1997) Summary page 2.
- K953574: Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer, American Hydro-Surgical Instruments, Inc. (1995) Summary page 2.

## Most influential descendants
- K153599: Concert Medical Hands-Free Syringe (HFS) (2016), 1 descendant of its own
- K230083: Safira (2023), 0 descendants of its own

## Indications for use
The Psi-Tec Syringe Infusion Pump and accessories indications for use are for General Fluid Irrigation/Infiltration.

Source page: https://510kreport.com/device/K980738
Methodology: https://510kreport.com/methodology