# K123729: Versarate Flow Rate Controler

- Pathway: 510(k) (Traditional)
- Applicant: Emed Technologies Corporation
- Decided: Dec 21, 2012 after 16 days
- Product code: FPA (Set, Administration, Intravascular)
- 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: 1 generation back to K890489 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890489: Extension Set W/Flow Regulator, Baxter Healthcare Corp (1989) Summary page 1.

## Indications for use
The VersaRateTM Flow Rate Controller is intended for use in the intravascular infusion of fluids to be delivered to the patient in a precise manner for no longer than 72 hours.

Source page: https://510kreport.com/device/K123729
Methodology: https://510kreport.com/methodology