# K141306: Tevadaptor; Connecting Set W/ Ultrasite Injection Site, Spike Port Adaptor Set W/ Ultrasite Injection Site

- Pathway: 510(k) (Special)
- Applicant: Teva Medical Ltd., Migada Plant
- Decided: Jun 12, 2014 after 24 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K121269 (2013). 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)
- K121269: TBA, Migada Plant (2013) Summary page 2.

## Indications for use
The I.V. Administration Set is a single use, sterile I.V. set for administration of drugs and/or fluids from a container to a patient vascular system.

Source page: https://510kreport.com/device/K141306
Methodology: https://510kreport.com/methodology