# K002690: Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500

- Pathway: 510(k) (Special)
- Applicant: Nonin Medical, Inc.
- Decided: Oct 11, 2000 after 43 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.
112 later devices descend from it; 7 cite it directly.
0 of 113 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
- K050056: Model 2500A Palmsat Pulse Oximeter (2005), 62 descendants of its own
- K022274: Carecompanion Patient Station & Nurse Station (2003), 39 descendants of its own
- K041308: Remotenurse Patient Monitoring System (2004), 34 descendants of its own
- K071285: Digital Pulse Oximeter, Model 7500 (2007), 29 descendants of its own
- K080798: Intel Health Guide, Model: PHS6000 (2008), 25 descendants of its own

## Recalls of this device
- Oct 15, 2007 · Not classified · Z-1092-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 11, 2007 · Not classified · Z-0843-2008: Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500.

Source page: https://510kreport.com/device/K002690
Methodology: https://510kreport.com/methodology