# K061115: Speedflow 0.2UM Filter, Model 11214; Speedflow 1.2UM Filter,  Model 11215; Easydrop Controller, Model 11216

- Pathway: 510(k) (Abbreviated)
- Applicant: Gvs Spa
- Decided: Jun 30, 2006 after 70 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) B. Braun; Filterflow Filtered Extension Sets: named in the summary without a submission number
- (no number) Amsino; IN. Administration Sets: named in the summary without a submission number
- (no number) Leventon; I.V. Extension Sets with I.V. Flow Regulators: named in the summary without a submission number

## Most influential descendants
- K181870: Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use (2019), 0 descendants of its own
- K080695: Mobile I.V. Systems 10,20,60 (2008), 0 descendants of its own

## Indications for use
Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration. Environment of use: Hospital, Emergency Medical Services settings, wherever I.V. fluid administration may be indicated.

Source page: https://510kreport.com/device/K061115
Methodology: https://510kreport.com/methodology