# K040589: Modification to Avant 9600 Pulse Oximeter

- Pathway: 510(k) (Special)
- Applicant: Nonin Medical, Inc.
- Decided: Jun 3, 2004 after 87 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: 6 generations back to K910772 (1991). 20 ancestors in all.
27 later devices descend from it; 5 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031487: Model Avant 2120 Pulse Oximeter and Nibp, Nonin Medical, Inc. (2004). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- 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
- K182822: Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System (2019), 6 descendants of its own
- K133661: Chair Sensing Unit for Earlysense System (2014), 6 descendants of its own

## Indications for use
The Nonin® AvantTM 9600 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, home care, and subacute environments. It may also be used in patient transport, sleep laboratories, and EMS environments. The AvantTM 9600 is intended for continuous monitoring and / or spot-checking of patients during both no motion and motion conditions, for patients who are well or poorly perfused.

Source page: https://510kreport.com/device/K040589
Methodology: https://510kreport.com/methodology