# K181870: Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan W.E.O Science & Technology Development Co., Ltd.
- Decided: Feb 26, 2019 after 229 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 K974661 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161898: Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set, Beijing Fert Technology Co., Ltd. (2017) Summary page 4.
- K974661: 0.2 U Bacterial Filter, Sims Deltec, Inc. (1998) Summary page 5.
- K061115: Speedflow 0.2UM Filter, Model 11214; Speedflow 1.2UM Filter,  Model 11215; Easydrop Controller, Model 11216, Gvs Spa (2006) Summary page 5.

## Indications for use
The Infusion Sets with Precision Filter for Single Use is indicated for the delivery of fluids from a container to a patient's vascular system for short term infusions only. The Precision Infusion Filter for Single Use is intended to be used with administration sets or extension sets for removal of particulate matter during the administration of fluids or medications. The Extended Infusion Sets for Single Use is intended to be used in I.V. therapy when an extended fluid path is requirement for administration.

Source page: https://510kreport.com/device/K181870
Methodology: https://510kreport.com/methodology