# K142333: Smart Label, Propofol

- Pathway: 510(k) (Traditional)
- Applicant: American I.V. Products, Inc. Dba Aiv, Inc.
- Decided: Dec 18, 2014 after 119 days
- Product code: MRZ (Accessories, Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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 K883577 (1988). 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)
- K883577: Bard Infusor Pump, C.R. Bard, Inc. (1988) Summary page 8.

## Indications for use
The Smart Label for Propofol is intended for controlled rate delivery of small volume parenteral fluids when used with the InfusO.R. Pump. The Smart Label is intended for use with Propofol as indicated on the label at the specified concentration for delivery using the syringe size also indicated on the Smart Label.

Source page: https://510kreport.com/device/K142333
Methodology: https://510kreport.com/methodology