# K950766: Sigma 8000 and Sigma 8002

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Intl. General Medical Apparatus, Inc.
- Decided: Mar 22, 1995 after 33 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
36 later devices descend from it; 4 cite it directly.
10 of 37 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
- 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
- K142374: ivWatch Model 400 (2015), 5 descendants of its own

Source page: https://510kreport.com/device/K950766
Methodology: https://510kreport.com/methodology