# K041156: Avant Digital Pulse Oximetry System, Models 4000, 4001

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Jun 9, 2004 after 37 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K910772 (1991). 12 ancestors in all.
89 later devices descend from it; 3 cite it directly.
0 of 102 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.

## Cited in the summary but kept off the family tree
- K030765: Hobbs Mistifier Spray Catheter, Hobbs Medical, Inc. (2003). Our reading of the summary gave K030765, FDA’s number for Hobbs Mistifier Spray Catheter (Hobbs Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Wireless Medicine LifeSync TM System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K043359: 4100 Patient Oximeter Module (2005), 75 descendants of its own
- K081285: Finger Pulse Oximeter, Model 9560 (2008), 40 descendants of its own
- K150314: Masimo MightySat Rx Fingertip Pulse Oximeter (2015), 24 descendants of its own
- K181956: Masimo MightySat Rx Fingertip Pulse Oximeter (2019), 23 descendants of its own
- K082113: Nox T3, Noxturnal (PC Application) (2008), 17 descendants of its own

## Recalls of this device
- Jul 29, 2005 · Not classified · Z-1457-05: The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break interoperatively.

## 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.

Source page: https://510kreport.com/device/K041156
Methodology: https://510kreport.com/methodology