# K050056: Model 2500A Palmsat Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Jun 21, 2005 after 161 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001930 (2000). 2 ancestors in all.
62 later devices descend from it; 8 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001930: Model 8500, Hand Held Pulse Oximeter, Model 8500, Nonin Medical, Inc. (2000) Summary page 1.
- K002690: Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500, Nonin Medical, Inc. (2000) Summary page 1.

## Most influential descendants
- K071285: Digital Pulse Oximeter, Model 7500 (2007), 29 descendants of its own
- K100077: Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103 (2010), 22 descendants of its own
- K101674: WVSM (Wireless Vital Signs Monitor), Model 5.0 (2010), 17 descendants of its own
- K142832: Unimed Disposable and Reusable SPO2 Sensors (2015), 14 descendants of its own
- K113165: Mini-Medic (2012), 13 descendants of its own

## Recalls of this device
- 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.

## Indications for use
The Nonin® Model 2500A Pulse Oximeter with Alarms is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and neonatal patients. It is intended for spot-checking and / or continuous monitoring of patients during motion and no motion conditions, and for patients who are well or poorly perfused.

Source page: https://510kreport.com/device/K050056
Methodology: https://510kreport.com/methodology