510(k) · Cleared
ClearedNposes (Nocturnal Pulse Oximetry Study Expert System), Model Nposes-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PHD Medical · DQA Oximeter
Cleared on Jun 29, 2006 as substantially equivalent to K033307 (Nonin Medical, Inc., 2004) after a 113-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jun 29, 2006
- Review
- 113 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K913695 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK913695 Nellcor (R) N-180 Pulse OximeterNellcor, Inc. · 1991
- 2 generations backK961450 Score SoftwareNellcor Puritan Bennett, Inc. · 1996
- 1 generation backK033307 Nvision Data Management SoftwareNonin Medical, Inc. · 2004
- This deviceK060616 Nposes (Nocturnal Pulse Oximetry Study Expert System), Model…PHD Medical · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913695 | Nellcor (R) N-180 Pulse Oximeter | Nellcor, Inc. | 1991 | — |
| −2 | K961450 | Score Software | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −1 | K033307 | Nvision Data Management Software | Nonin Medical, Inc. | 2004 | — |
| 0 (this device) | K060616 | Nposes (Nocturnal Pulse Oximetry Study Expert System), Model Nposes-100 | PHD Medical | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033307 | Nvision Data Management SoftwareSummary page 1…OSES Common/Usual Name: Pulse Oximeter Data Management Software Classification Name: Oximeter Predicate Devices nVISION Data Management Software (K033307), manufactured by Nonin Medical, Inc. Description of the Device The PHD Medical NPOSES (Nocturnal Pulse Oximetry Study Expert… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K033307.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
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…
Read the full statement (153 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060616: Nposes (Nocturnal Pulse Oximetry Study Expert System), Model Nposes-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060616
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026