# K121092: Flowease [Subcutaneous] Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 29, 2012 after 80 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: 5 generations back to K831445 (1983). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925362: Sub-Q-Set (R) Subcutaneous Infusion Set, Baxter Healthcare Corp (1993) Summary page 1.
- K102512: RMS Subcutaneous Needle Set, Repro-Med Systems, Inc. (2011) Summary page 1.
- K020530: Evans Sub-Q, Model MC4206, Evans Medical, Inc. (2002) Summary page 1.

## Indications for use
Intended for the subcutaneous infusion of fluid medicines.

Source page: https://510kreport.com/device/K121092
Methodology: https://510kreport.com/methodology