# K031487: Model Avant 2120 Pulse Oximeter and Nibp

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Mar 22, 2004 after 315 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K910772 (1991). 19 ancestors in all.
42 later devices descend from it; 3 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013319: Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor, Nonin Medical, Inc. (2002) Summary page 1.
- K993637: N-395 Pulse Oximeter, with Extended Device Claims, Nellcor Puritan Bennett, Inc. (1999) Summary page 2.
- K013792: Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables, Masimo Corp. (2001) Summary page 2.

## Most influential descendants
- K040589: Modification to Avant 9600 Pulse Oximeter (2004), 27 descendants of its own
- K053209: Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System (2006), 13 descendants of its own
- K120465: Earlysense (Everon) System (2012), 9 descendants of its own
- K131379: Earlysense (2013), 7 descendants of its own
- K092101: Reusable Pulse Oximeter Sensor, Model 8000 Series (2009), 7 descendants of its own

## Indications for use
The Nonin® Model Avant TM 2120 Pulse Oximeter and NIBP Monitor is a portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO 2 ), pulse rate, and blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The Model 2120 is intended for spot-checking and / or continuous monitoring of patients during both no motion and motion conditions, for patients who are well or poorly perfused. Its'functions may be used separately or simultaneously.

Source page: https://510kreport.com/device/K031487
Methodology: https://510kreport.com/methodology