# K060616: Nposes (Nocturnal Pulse Oximetry Study Expert System), Model Nposes-100

- Pathway: 510(k) (Traditional)
- Applicant: PHD Medical
- Decided: Jun 29, 2006 after 113 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: 3 generations back to K913695 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033307: Nvision Data Management Software, Nonin Medical, Inc. (2004) Summary page 1.

## Indications for use
The intended use of NPOSES (Nocturnal Pulse Oximetry Study Expert System) software is to collect, analyze, report and archive oximetry trend data to provide information to a Medical Doctor specializing in sleep medicine, as a supplemental tool to assist in the timely diagnosis of pediatric obstructive sleep apnea (OSA). NPOSES is intended for use by an MD/Respiratory Specialist through the following process steps (1) recording and transferring data from a pulse oximeter to a computer in order to maintain unique records per patient of pulse oximetry data, (2) analyzing. reviewing and validating patient data and summary statistics according to customized. user-selected parameters, and (3) generating and archiving reports. NPOSES in itself is not a diagnosis tool. It is a decision management tool which allows medical personnel to upload and view data related to a sleep study and provide output reports as feedback which may be used by an MD to form a diagnosis.

Source page: https://510kreport.com/device/K060616
Methodology: https://510kreport.com/methodology