510(k) · Cleared
ClearedEvision Data Management Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nonin Medical, Inc. · DQA Oximeter
Cleared on Oct 1, 2009 as substantially equivalent to K033307 (Nonin Medical, Inc., 2004) after a 30-day review. Its family tree reaches back 3 generations to 1991. 4 later devices descend from it.
- Decided
- Oct 1, 2009
- Review
- 30 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. 4 later devices descend from it, 1 citing it directly.
- 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 deviceK092678 Evision Data Management SoftwareNonin Medical, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK132402 Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK160865 Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter…Nonin Medical, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK233827 OxiWearOxiwear, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK192900 H500 Multi-Sensing Oximetry SystemNonin Medical, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · cites it directly3descendants
- K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc. · 2016 · 2 generations on1descendant
- K233827OxiWearOxiwear, Inc. · 2024 · 3 generations on0descendants
- K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc. · 2020 · 2 generations on0descendants
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) | K092678 | Evision Data Management Software | Nonin Medical, Inc. | 2009 | — |
| +1 | K132402 | Sensmart Model X-100 Univeral Oximetry System | Nonin Medical, Inc. | 2014 | 1 |
| +2 | K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors… | Nonin Medical, Inc. | 2016 | — |
| +3 | K233827 | OxiWear | Oxiwear, Inc. | 2024 | — |
| +2 | K192900 | H500 Multi-Sensing Oximetry System | Nonin Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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…Software Classification Name: and Number: Class II, 21 CFR 870.2700 Predicate Device(s): Nonin's nVISION Data Management Software (K033307) cleared on 05/06/2004. Device Description: eVISION® Data Management Software (eVISION) is an optional… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132402 | Sensmart Model X-100 Univeral Oximetry System | 2014 | 3 |
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 18 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K132402 (Nonin Medical, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 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. 2009, 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?
eVISION® Data Management Software (eVISION) is an optional accessory for use with Nonin's Model 7600 Regional Oximeter System. It is intended for use by healthcare professionals when 1) transferring data from the Model 7600 to a computer in order to maintain individual records of regional oximetry data, 2) reviewing data according to user-selected parameters, and 3) generating reports.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092678 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092678: Evision Data Management Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092678
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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