# K953896: The Imed Ambulatory Infusion Pump, Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Imed Corp.
- Decided: Mar 20, 1996 after 216 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CADD series of ambulatory infusion pumps (CADD-PCA®, CADD-TPN™, and CADD-PLUS®): named in the summary without a submission number
- (no number) Gemini series of IV Administration Sets: named in the summary without a submission number

## Most influential descendants
- K093332: Delphi Infusion Pump/ Delphi Administration Set  Model IV-01000/ Model IV-02XXXX (Where X IS Any Number Between 0-9) (2009), 0 descendants of its own

## Recalls of this device
- Mar 29, 2006 · Not classified · Z-1445-06: Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm.

## Indications for use
The IMED Ambulatory Infusion System is intended for use in a health care facility as well as home health care setting to pump standard IV fluids, medications, blood and blood products into a patient in a controlled manner. The system is electrically powered, with back up battery power available, and uses rotary peristaltic pumping action to infuse fluids. The IMED Ambulatory Infusion System is capable of detecting air-in-line and occlusions.

Source page: https://510kreport.com/device/K953896
Methodology: https://510kreport.com/methodology