# K052790: Smartsite Vented Vial  Access Device, Model TBD

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Alaris Products
- Decided: Dec 23, 2005 after 81 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- 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: 2 generations back to K901063 (1990). 6 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983794: Chemo Mini Spike Plus, B. Braun of America, Inc. (1999) Summary page 2.
- K970485: Smartsite Access Pin, Ivac Medical Systems (1997) Summary page 2.

## Most influential descendants
- K151963: SmartSite Vented Vial Access Device (2015), 1 descendant of its own
- K132863: Smartsite Vialshield (2013), 1 descendant of its own
- K243486: SmartSiteTM Vented Vial Access Device (2024), 0 descendants of its own
- K172884: Arisure Closed Vial Adapter (2017), 0 descendants of its own
- K072511: Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MM (2007), 0 descendants of its own

## Indications for use
The SmartSite® Vented Vial Access Device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

Source page: https://510kreport.com/device/K052790
Methodology: https://510kreport.com/methodology