510(k) · Cleared
ClearedOxiscan II Data Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airsep Corp. · DQA Oximeter
Cleared on Oct 9, 2008 as substantially equivalent to K033307 (Nonin Medical, Inc., 2004) after a 241-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Oct 9, 2008
- Review
- 241 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 deviceK080348 Oxiscan II Data Management SystemAirsep Corp. · 2008
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) | K080348 | Oxiscan II Data Management System | Airsep Corp. | 2008 | — |
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…ftware is substantially equivalent to Nonin Medicals "InVISION" software (K033307) Device Description: OxiScan 11 Oximetry Data Management Software is an… | 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 17 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. 2008, this device’s year, is highlighted.
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?
OxiScan II Oximetry Data Management Software (OxiScan II) is a central server based software system that uses a personal computer based application written in Microsoft Dot Net protocol to capture oximetry data from an oximeter, and then transmit this data, in a secure encrypted file, via internet, to the central server. At the central server the data is used to render a standard report that is then transmitted via fax and/or email to the prescribing…
Read the full statement (248 words)
OxiScan II Oximetry Data Management Software (OxiScan II) is a central server based software system that uses a personal computer based application written in Microsoft Dot Net protocol to capture oximetry data from an oximeter, and then transmit this data, in a secure encrypted file, via internet, to the central server. At the central server the data is used to render a standard report that is then transmitted via fax and/or email to the prescribing physician. The intended use of the report is to provide a physician with information to help determine the best pulmonary treatment.
The OxiScan I1Oximetry Data Management Software is intended to collect, report and archive oximetry trend data to provide information to a medical professional, as a supplemental tool to assist in the timely identification of pulmonary needs.
The OxiScan II Oximetry Data Management Software is intended to (1) transfer oximetry data from a pulse oximeter to a central server data base in order to maintain unique records per patient and test of this pulse oximetry data, and (2) to generate and archive standard reports drawn from this data. A list of approved oximeters appears in the Capture software.
The OxiSean IL Oximetry Data Management Software is not a diagnosis tool. It is a decision management support tool that allows medical personnel to securely and accurately upload and view data related to pulse oximetry and to provide output reports as feedback which may be used by a Heathcare professional to form a patient history.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080348 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080348: Oxiscan II Data Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080348
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