# K052669: Avant Digital Pulse Oximetry System, Model 4000, 4100

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Dec 23, 2005 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). 13 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041156: Avant Digital Pulse Oximetry System, Models 4000, 4001, Nonin Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K092101: Reusable Pulse Oximeter Sensor, Model 8000 Series (2009), 7 descendants of its own
- K132402: Sensmart Model X-100 Univeral Oximetry System (2014), 3 descendants of its own
- K172586: Vios Monitoring System™ Model 2050 (2018), 2 descendants of its own
- K162580: Guardian Angel GA1000 Digital Vital Sign Monitoring System (2017), 2 descendants of its own
- K160865: Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso (2016), 1 descendant of its own

## Indications for use
The Nonin® Avant® Model 4000 Digital Pulse Oximetry System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and no motion conditions, and for patients who are well or poorly perfused.

Source page: https://510kreport.com/device/K052669
Methodology: https://510kreport.com/methodology