# K023044: Model 9600, Avant Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Jul 23, 2003 after 314 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 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) Nonin Model Avant 7120 Pulse Oximeter Non Invasive Blood Pressure (NIBP) Monitor: named in the summary without a submission number

## Most influential descendants
- K093853: Single-Patient Use Disposable Sensor Series (2010), 2 descendants of its own
- K124049: Deepview Digital Video Physiological Portable Imaging System (2013), 1 descendant of its own
- K163339: Spectralmd Deepview Wound Imaging System 2.0 (2017), 0 descendants of its own
- K103685: Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN, RSJ002DA, RSJ091DI, RST063CA (2011), 0 descendants of its own
- K103584: Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda  Compatible Disposable and Reusable SPO2 Sensors (2011), 0 descendants of its own

## Indications for use
The NONIN® AVANT™ 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 is also used in patient transport, sleep laboratories, and EMS environments. The Avant 9600 is intended for continuous monitoring and/or spot-checking of patients.

Source page: https://510kreport.com/device/K023044
Methodology: https://510kreport.com/methodology