# K033307: Nvision Data Management Software

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: May 6, 2004 after 205 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: 2 generations back to K913695 (1991). 3 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001708: Profox Software, Model 920M-41, Respironics Georgia, Inc. (2001) Summary page 1.
- K961450: Score Software, Nellcor Puritan Bennett, Inc. (1996) Summary page 2.

## Most influential descendants
- K092678: Evision Data Management Software (2009), 4 descendants of its own
- K132402: Sensmart Model X-100 Univeral Oximetry System (2014), 3 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
- K233827: OxiWear (2024), 0 descendants of its own
- K192900: H500 Multi-Sensing Oximetry System (2020), 0 descendants of its own

## Indications for use
nVISION® Data Management Software (nVISION) is an optional accessory for compatible Nonin oximeters with memory playback. nVISION Is Indicated for use with the following Nonin oximeters: 9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, and 9840. It Is Intended for use by healthcare professionals when (1) transferring data from pulse oximeters to computers in order to maintain Individual records of pulse oximetry data, (2) reviewing that data according to user-selected parameters, and (3) generating reports.

Source page: https://510kreport.com/device/K033307
Methodology: https://510kreport.com/methodology