# K993832: Autodose Infusion System, Model AD4120, BE4210, S12050,100,200, FF0005, 10

- Pathway: 510(k) (Traditional)
- Applicant: Tandem Medical, Inc.
- Decided: Feb 9, 2000 after 89 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- 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: 3 generations back to K915646 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990889: Autodose Infusion System, Tandem Medical, Inc. (1999) Summary page 1.

## Indications for use
The AutoDose Infusion system is intended for sequential infusion of predetermined volumes of intravenous solutions including 0.9% Sodium Chloride Injection, (NaCl), and Heparin Lock Flush Solution, USP solutions,

Source page: https://510kreport.com/device/K993832
Methodology: https://510kreport.com/methodology