# K940446: 3M Model 3000 & Model 3100 Infusion Pump (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Minnesota Mining and Mfg. Co.
- Decided: Aug 15, 1994 after 195 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (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
- Feb 27, 2008 · Not classified · Z-1604-2008: The Deltec, Graseby, and 3M, Large Volume Infusion Pump - Models 3000 and 3100, may deliver an unintended bolus if the pump door is opened and then immediately closed. This problem is due to a timing 
- Feb 27, 2008 · Not classified · Z-1605-2008: The Deltec, Graseby, and 3M, Large Volume Infusion Pump - Models 3000 and 3100, may deliver an unintended bolus if the pump door is opened and then immediately closed. This problem is due to a timing 

Source page: https://510kreport.com/device/K940446
Methodology: https://510kreport.com/methodology