# K030668: Model 3100 Wristox Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Oct 17, 2003 after 228 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
Longest line of descent: 1 generation back to K002690 (2000). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K040178: Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device (2004), 5 descendants of its own
- K202483: MyHomeDoc (2021), 1 descendant of its own
- K170181: Prizma (2017), 1 descendant of its own
- K223785: N9+ (2023), 0 descendants of its own
- K173589: Prizma (2018), 0 descendants of its own

## Indications for use
The Nonin Model 3 100 WristOxTMPulse Oximeter is a srnalI, wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterid hemoglobin (Sp02) and pulse rate. It may be used for spot-checking and/or data collection and recording of adult and pediatric patients in hospitals, mediczll facilities, ambulatory, subacute, and sleep study environments

Source page: https://510kreport.com/device/K030668
Methodology: https://510kreport.com/methodology