# K010966: Medley SP02 Module, Model 8220

- Pathway: 510(k) (Traditional)
- Applicant: Alaris Medical Systems, Inc.
- Decided: Jun 8, 2001 after 67 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- 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.
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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022677: Medley SPO2 Module, Model 8210 & SPO2 Sensors & Cable (2002), 0 descendants of its own

## Recalls of this device
- Mar 5, 2008 · Not classified · Z-1712-2008: A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failure of the U9 Socketed Integrated Circuits 
- Mar 5, 2008 · Not classified · Z-1711-2008: A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors with the Alaris System due to the Inter-Unit Interface

Source page: https://510kreport.com/device/K010966
Methodology: https://510kreport.com/methodology