# K895797: Imed 4100 and 4200 Disposable Infusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Imed Corp.
- Decided: Jan 2, 1990 after 96 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 19, 2008 · Not classified · Z-1170-2009: The recall was initiated as a result of a potential for out of specification flow rates. The product may not consistently meet the labeled flow rate range of +/- 15%.

Source page: https://510kreport.com/device/K895797
Methodology: https://510kreport.com/methodology