# K172242: DripAssist Plus

- Pathway: 510(k) (Traditional)
- Applicant: Shift Labs, Inc.
- Decided: May 25, 2018 after 303 days
- Product code: FLN (Monitor, Electric For Gravity Flow Infusion Systems)
- Device class: 2
- Regulation: 21 CFR 880.2420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002211 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150687: DripAssist, Shift Labs (2015) Summary page 4.

## Indications for use
The DripAssist Plus is a device intended to be used with gravity infusions as a supplementary monitor that measures the flow of fluid through a compatible drip chamber. The device is intended to be used with single-use intravascular administration sets uniquely identified as “compatible with DripAssist Plus.” Sensors measure the flow rate and calculations are performed to convert the drip rate to mL/hr measurement and total volume. An alarm is available to alert the user if the drip rate deviates from the set infusion rate setting controlled through the IV administration set.

Source page: https://510kreport.com/device/K172242
Methodology: https://510kreport.com/methodology