# K143082: IV Administration Sets with 200(micro)m Blood Filter

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jul 24, 2015 after 270 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: 3 generations back to K030467 (2003). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101677: Hospira Infusion Blood Sets, Hospira, Inc. (2010) Summary page 4.

## Most influential descendants
- K213846: Q2 Blood Administration Sets (2022), 0 descendants of its own

## Indications for use
The IV Administration Sets with 200μm Blood Filter are used to deliver blood, blood components, and IV fluids from a container to a patient's vascular system. When the hand pump component is activated, the device is intended to deliver blood, blood products and crystalloid and colloid resuscitative fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and the duration of therapy.

Source page: https://510kreport.com/device/K143082
Methodology: https://510kreport.com/methodology