# K202618: IV Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Sep 24, 2021 after 379 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K942988 (1995). 47 ancestors in all.
No later device cites it as a predicate yet.
4 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170595: IV Administration Sets, B.Braun Medical, Inc. (2017) Summary page 4.
- K153293: Extension Set, B.Braun Medical, Inc. (2016) Summary page 4.

## Recalls of this device
- Oct 29, 2025 · Class II · Z-0710-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

## Indications for use
IV Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. 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 duration of therapy. Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. 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 duration of therapy.

Source page: https://510kreport.com/device/K202618
Methodology: https://510kreport.com/methodology