# K142097: Selec-3 I.V.Administration Set

- Pathway: 510(k) (Special)
- Applicant: Biomedix, Inc.
- Decided: Aug 29, 2014 after 28 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: 1 generation back to K925645 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925645: SELEC-3, Biomedix, Inc. (1993) Summary page 4.

## Recalls of this device
- Aug 14, 2014 · Class II · Z-0023-2015: Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insuffici

## Indications for use
The SELEC-3 I.V. Administration Set is used to provide a pathway to deliver fluid into the body via the vascular system. This product is targeted for use by nurses and paramedics in pre-hospital, emergency room and field settings.

Source page: https://510kreport.com/device/K142097
Methodology: https://510kreport.com/methodology