# K191658: IV Sets not made with PVC

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Mar 19, 2020 after 272 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-0623-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

## Indications for use
The IV Administration Sets not made with PVC are intravenous administration sets intended for delivery of fluids from a container into a patient’s vascular system. The IV Extension Sets not made with PVC may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids, medications, blood and blood products.

Source page: https://510kreport.com/device/K191658
Methodology: https://510kreport.com/methodology