# K043359: 4100 Patient Oximeter Module

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Jan 7, 2005 after 32 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.
75 later devices descend from it; 4 cite it directly.
0 of 89 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
- 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
- K083309: Zargis Acoustic Cardioscan, Version 9.33 (2009), 14 descendants of its own

## Indications for use
The Nonin Bluetooth® - enabled Model 4100 Patient Oximeter Module is indicated for use in measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and plethysmographic data to a compatible Bluetooth,- enabled device.

Source page: https://510kreport.com/device/K043359
Methodology: https://510kreport.com/methodology