# K200893: ProntoPump Sterile Tube Set

- Pathway: 510(k) (Traditional)
- Applicant: Ipax, Inc.
- Decided: May 4, 2021 after 396 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K872743 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062909: Repeater Pump II Tube Sets, Baxa Corp. (2007) Summary page 5.

## Indications for use
The Pronto Pump Tube Set is a part of the Pronto Pump System. This tube set provides peristaltic pump driven fluid transfer that facilities repeatable drug dosage distribution and reconstitution in healthcare environments. The Pronto Pump Tube set provides the fluid path way and pumping mechanism for the pump system. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.

Source page: https://510kreport.com/device/K200893
Methodology: https://510kreport.com/methodology