# K153293: Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Apr 6, 2016 after 145 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K942988 (1995). 17 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083472: Medegen Pressure Rated Extension Sets, Medegen, Inc. (2008) Summary page 4.
- K140831: Maxzero Extension Set with Needless Connector, Care Fusion (2014) Summary page 4.

## Most influential descendants
- K230528: Extension Set (2023), 0 descendants of its own
- K202618: IV Administration Sets (2021), 0 descendants of its own
- K191658: IV Sets not made with PVC (2020), 0 descendants of its own

## Recalls of this device
- Oct 29, 2025 · Class II · Z-0611-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0612-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0665-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0673-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0630-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0669-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0674-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Mar 15, 2021 · Class II · Z-1509-2021: BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.

## Indications for use
B. Braun Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids, medications, blood and blood products. Select sets may be used with power injector procedures to a maximum pressure of 400 psi and a maximum flow rate of 15 mL per second. B. Braun's optional stabilization component on an extension set provides stability to an intravascular catheter by supporting the patient connector. B. Braun Extension Sets may be used for any patient population.

Source page: https://510kreport.com/device/K153293
Methodology: https://510kreport.com/methodology