# K102350: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Dec 22, 2010 after 125 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Model 3100 WristOx: named in the summary without a submission number

## Most influential descendants
- K191697: Cardiac Monitor 1500 (2020), 1 descendant of its own
- K223217: Zynex Monitoring System, Model CM-1600 (2023), 0 descendants of its own
- K120052: Cvinsight (2012), 0 descendants of its own

## Indications for use
The Nonin Model 3100 WristaxT Pulse Oximeter is a small, wrist-worn device indicated for use is measuring, displaying and storing functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate. It may be used for spot-checking and/or data collection and recording of adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused. The intended use environments are hospitals, medical facilities, ambulatory, subacute, sleep study environments, and mobile units.

Source page: https://510kreport.com/device/K102350
Methodology: https://510kreport.com/methodology