# K953098: Volumetric Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Dec 22, 1995 after 172 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K961703: Colleague 2 Volumetric Infusion Pump (Dual Channel)/Colleague 3 Volumetric Infusion Pump (Tree Channel) (1996), 0 descendants of its own

## Recalls of this device
- Nov 4, 2004 · Not classified · Z-0342-05: A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the pati
- Apr 13, 2004 · Not classified · Z-0879-04: Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.
- Jul 16, 2003 · Not classified · Z-1151-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

Source page: https://510kreport.com/device/K953098
Methodology: https://510kreport.com/methodology