# K161800: OnSite-IV

- Pathway: 510(k) (Traditional)
- Applicant: Pharmc, LLC
- Decided: Dec 6, 2016 after 159 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: 5 generations back to K894177 (1989). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133097: E-Z Link, Duoject Medical Systems, Inc. (2014) Summary page 4.
- K925401: IV Fluid Transfer Pin, B. Braun of America, Inc. (1993) Summary page 4.

## Indications for use
The OnSite-IV™ is a single use sterile device for the preparation and / or transfer of drugs from a standard pharmaceutical vial into an elastomeric pump or IV bag.

Source page: https://510kreport.com/device/K161800
Methodology: https://510kreport.com/methodology