# K831087: Mini-Vol Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Beech Medical, Inc.
- Decided: Apr 28, 1983 after 24 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 4, 2015 · Class II · Z-1730-2015: Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product.

Source page: https://510kreport.com/device/K831087
Methodology: https://510kreport.com/methodology