# K002211: Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump 2M8151

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corp
- Decided: Jul 28, 2000 after 7 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
43 later devices descend from it; 2 cite it directly.
12 of 44 devices 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.

## Most influential descendants
- K042121: Spectrum and Spectrum with Master Drug Library (2004), 28 descendants of its own
- K133801: Baxter Sigma Spectrum Infusion Pump with Master Drug Library (2014), 18 descendants of its own
- K012383: Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii), Medsystem Patient C (2001), 13 descendants of its own
- K173084: Spectrum IQ Infusion System, Dose IQ Safety Software (2018), 9 descendants of its own
- K123049: Sapphire Infusion Pump (2013), 7 descendants of its own

## Recalls of this device
- Nov 4, 2004 · Not classified · Z-0344-05: 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
- Nov 4, 2004 · Not classified · Z-0345-05: 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-0882-04: 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.
- Apr 13, 2004 · Not classified · Z-0881-04: 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.

Source page: https://510kreport.com/device/K002211
Methodology: https://510kreport.com/methodology